N361297 New York Ruling Active

The tariff classification of SILKBridge® Biointegrative Nerve Guide from Italy

Issued May 21, 2026 by U.S. Customs and Border Protection.

Tariff classification

HTS codes: 9021.90.8100

Headings: 9021

Product description

SILKBridge® Biointegrative Nerve Guide is a sterile, bioengineered tubular implant designed for thesurgical repair of peripheral nerve discontinuities. The device features a three-layered wall structure: anintermediate textile layer of native silk fibers encased by inner and outer electrospun silk fibroin layers,forming a biomimetic, macro- and microporous wall. Severed nerve extremities are placed inside the device. The nerve guide protects the injured nerve, ensures nutrient influx, and supports axonal growth until nervecontinuity is restored. The device is semipermeable, non-constrictive, and intended to be graduallybioabsorbed through enzymatic degradation in parallel with vascularized neotissue ingrowth, ultimatelybeing replaced by native tissue. It is produced through a controlled sequence of operations, including silkfibroin extraction, textile fabrication, electrospinning, multilayer assembly, and terminal sterilization. Thedevice is available in various sizes to match nerve injuries and is packaged in double sterile pouches with anexternal carton.

CBP rationale

The applicable subheading for the SILKBridge® Biointegrative Nerve Guide will be 9021.90.8100,Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Orthopedic appliances,including crutches, surgical belts and trusses; splints and other fracture appliances; artificial parts of thebody; hearing aids and other appliances which are worn or carried, or implanted in the body, to compensatefor a defect or disability; parts and accessories thereof: Other: Other.

Full text

N361297May 21, 2026CLA-2-90:OT:RR:NC:N3:135
CATEGORY: Classification
TARIFF NO.: 9021.90.8100
Lorenzo SalaKLISBio SrlVia L. Ariosto, 21Bresso 20091ItalyRE: The tariff classification of SILKBridge® Biointegrative Nerve Guide from ItalyDear Mr. Sala:In your letter dated
May 6, 2026
, you requested a tariff classification ruling.SILKBridge® Biointegrative Nerve Guide is a sterile, bioengineered tubular implant designed for thesurgical repair of peripheral nerve discontinuities. The device features a three-layered wall structure: anintermediate textile layer of native silk fibers encased by inner and outer electrospun silk fibroin layers,forming a biomimetic, macro- and microporous wall. Severed nerve extremities are placed inside the device. The nerve guide protects the injured nerve, ensures nutrient influx, and supports axonal growth until nervecontinuity is restored. The device is semipermeable, non-constrictive, and intended to be graduallybioabsorbed through enzymatic degradation in parallel with vascularized neotissue ingrowth, ultimatelybeing replaced by native tissue. It is produced through a controlled sequence of operations, including silkfibroin extraction, textile fabrication, electrospinning, multilayer assembly, and terminal sterilization. Thedevice is available in various sizes to match nerve injuries and is packaged in double sterile pouches with anexternal carton.The applicable subheading for the SILKBridge® Biointegrative Nerve Guide will be 9021.90.8100,Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Orthopedic appliances,including crutches, surgical belts and trusses; splints and other fracture appliances; artificial parts of thebody; hearing aids and other appliances which are worn or carried, or implanted in the body, to compensatefor a defect or disability; parts and accessories thereof: Other: Other.” The rate of duty will be free.The duties cited above are current as of this ruling’s issuance. Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are providedat https://hts.usitc.gov/.
This ruling does not address the applicability of any additional duties, taxes, fees, exactions and/or othercharges, which may apply to the goods discussed herein. This includes, but is not limited to, tariffs and otherduties as provided for in Subchapter III to Chapter 99, HTSUS.Thus, for example, in addition to the classification stated above, the merchandise covered by this ruling may also need to be reported with eitherthe Chapter 99 provision under which an additional tariff applies or one of the Chapter 99 provisionscovering exceptions to such tariffs.For further information to assist with the importation process, please refer to the frequently updated CargoSystems Messaging Service (CSMS) messages at https://www.cbp.gov/trade/automated/cargo-systems-messaging-service and the Trade Remedies page at https://www.cbp.gov/trade/programs-administration/trade-remedies.The holding set forth above applies only to the specific factual situation and merchandise description asidentified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations(CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of theinformation furnished in the ruling letter, whether directly, by reference, or by implication, is accurate andcomplete in every material respect. In the event that the facts are modified in any way, or if the goods do notconform to these facts at time of importation, you should bring this to the attention of U.S. Customs andBorder Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodicverification by CBP.This ruling is being issued under the provisions of Part 177 of the Customs and Border ProtectionRegulations (19 C.F.R. 177).A copy of the ruling or the control number indicated above should be provided with the entry documentsfiled at the time this merchandise is imported. If you have any questions regarding the ruling, please contactNational Import Specialist Fei Chen at [email protected].
Sincerely,
(for)James P. ForkanDirectorNational Commodity Specialist Division

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