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 Flexor Tendon Repair Implant kit with Multifilament Stainless Steel Sutures and SS Crimp. Each Kit contains: 1x size #3-0 MFSS suture with 2 curved needles (white wrap) 1x size #3-0 MFSS suture with 2 curved needles (black wrap) 1x SS Crimp Collar Supplied pouched, sterilized with EO. FDA UDI
Model / Reference: 400-3011 FDA UDI
Description: PONTiS Flexor Tendon Repair Implant kit with Multifilament Stainless Steel Sutures and SS Crimp. Each Kit contains: 1x size #3-0 MFSS suture with 2 curved needles (white wrap) 1x size #3-0 MFSS suture with 2 curved needles (black wrap) 1x SS Crimp Collar Supplied pouched, sterilized with EO. FDA UDI

Identifiers

Catalog Number: 400-3011 FDA UDI
Primary DI / UDI-DI: 00859210006001 FDA UDI
FDA Product Code: MBI FDA UDI
GAQ FDA UDI
GMDN Term: Metallic suture, multifilament FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
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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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 61ecd0f2-5b8d-42f7-9578-537c3f080951 35 fields · synced Jun 1, 2026