ComposiTCP™

FDA UDI

Class II (US FDA UDI)

by S.b.m

Identity

Trade Name: ComposiTCP™ FDA UDI
Generic Name: Bone tap, reusable FDA UDI
Device Name: Ø4.5 mm suture anchor punch tap FDA UDI
Model / Reference: Suture Anchor Punch Tap FDA UDI
Description: Ø4.5 mm suture anchor punch tap FDA UDI

Identifiers

Catalog Number: 110026111 FDA UDI
Primary DI / UDI-DI: 03760154008273 FDA UDI
510(k) Number: K170868 FDA UDI
FDA Product Code: MAI FDA UDI
GMDN Term: Bone tap, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Bone tap, reusable

ComposiTCP™ by S.b.m — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone tap, reusable.

BIOSURE — Smith & Nephew, Inc. · Class I
NobelActive® — Nobel Biocare AG · Class I
CORTICAL TAP — Biomet Orthopedics, Inc. · Class I
PressON™ — NEXUS SPINE, L.L.C. · Class I
Insite — TORNIER, INC. · Class I
ReLine — Nuvasive, Inc. · Class I
Mariner MIS — SeaSpine Orthopedics Corporation · Class I
Response 5.5/6.0 Spine System — ORTHOPEDIATRICS CORP. · Class I

Cleared under the same submission

K170868 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: S.b.m

Sources (1)

FDA UDI 09dca3ff-8538-4d7a-9656-f063f69f827f 35 fields · synced Jun 8, 2026