CLA-2-90:OT:RR:NC:N3:135
Lorenzo Sala
KLISBio Srl
Via L. Ariosto, 21
Bresso 20091
Italy
RE: The tariff classification of SILKBridge® Biointegrative Nerve Guide from Italy
Dear 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 the
surgical repair of peripheral nerve discontinuities. The device features a three-layered wall structure: an
intermediate 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 nerve
continuity is restored. The device is semipermeable, non-constrictive, and intended to be gradually
bioabsorbed through enzymatic degradation in parallel with vascularized neotissue ingrowth, ultimately
being replaced by native tissue. It is produced through a controlled sequence of operations, including silk
fibroin extraction, textile fabrication, electrospinning, multilayer assembly, and terminal sterilization. The
device is available in various sizes to match nerve injuries and is packaged in double sterile pouches with an
external 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 the
body; hearing aids and other appliances which are worn or carried, or implanted in the body, to compensate
for 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 provided
at https://hts.usitc.gov/.
This ruling does not address the applicability of any additional duties, taxes, fees, exactions and/or other
charges, which may apply to the goods discussed herein. This includes, but is not limited to, tariffs and other
duties 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 either
the Chapter 99 provision under which an additional tariff applies or one of the Chapter 99 provisions
covering exceptions to such tariffs.
For further information to assist with the importation process, please refer to the frequently updated Cargo
Systems 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 as
identified 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 the
information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and
complete in every material respect. In the event that the facts are modified in any way, or if the goods do not
conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and
Border 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 periodic
verification by CBP.
This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection
Regulations (19 C.F.R. 177).
A copy of the ruling or the control number indicated above should be provided with the entry documents
filed at the time this merchandise is imported. If you have any questions regarding the ruling, please contact
National Import Specialist Fei Chen at [email protected].
Sincerely,
(for)
James P. Forkan
Director
National Commodity Specialist Division