PONTiS Flexor Tendon Repair System

FDA UDI

Class II (US FDA UDI)

by Pontis Orthopaedics, LLC

Identity

Trade Name: PONTiS Flexor Tendon Repair System FDA UDI
Generic Name: Metallic suture, multifilament FDA UDI
Device Name: PONTiS Crimp Collar for Flexor Tendon Repair Each Unit contains: 1x SS Crimp Collar for use with PONTiS size #3-0 multifilament SS sutures. Supplied pouched, sterilized with EO. FDA UDI
Model / Reference: 401-3006 FDA UDI
Description: PONTiS Crimp Collar for Flexor Tendon Repair Each Unit contains: 1x SS Crimp Collar for use with PONTiS size #3-0 multifilament SS sutures. Supplied pouched, sterilized with EO. FDA UDI

Identifiers

Catalog Number: 401-3006 FDA UDI
Primary DI / UDI-DI: 00859210006032 FDA UDI
510(k) Number: K081060 FDA UDI
FDA Product Code: GAQ FDA UDI
GMDN Term: Metallic suture, multifilament FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4495 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Metallic suture, multifilament

PONTiS Flexor Tendon Repair System by Pontis Orthopaedics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Metallic suture, multifilament.

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DemeSTEEL — DemeTECH Corp · Class II
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Bioseal Inc. — BIOSEAL · Class I
Bioseal Inc. — BIOSEAL · Class I
DemeSTEEL — DemeTECH Corp · Class II

Cleared under the same submission

K081060 also covers:

PONTiS Flexor Tendon Repair System — Pontis Orthopaedics, LLC

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: Pontis Orthopaedics, LLC

Sources (1)

FDA UDI 8277592a-2da5-4f7b-99c3-18532c572e1d 36 fields · synced May 30, 2026