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: Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
Device Name: PONTiS 3mm Anchor with Anchor Driver for Flexor Tendon Repair Each Kit contains: 1x 3mm Anchor with Driver handle Anchor has size #3-0 multifilament SS suture Each end of SS suture has pre-attached straight needles. Supplied pouched, sterilized with EO. FDA UDI
Model / Reference: 400-3031 FDA UDI
Description: PONTiS 3mm Anchor with Anchor Driver for Flexor Tendon Repair Each Kit contains: 1x 3mm Anchor with Driver handle Anchor has size #3-0 multifilament SS suture Each end of SS suture has pre-attached straight needles. Supplied pouched, sterilized with EO. FDA UDI

Identifiers

Catalog Number: 400-3031 FDA UDI
Primary DI / UDI-DI: 00859210006025 FDA UDI
510(k) Number: K101126 FDA UDI
K133579 FDA UDI
FDA Product Code: GAQ FDA UDI
MBI FDA UDI
GMDN Term: Tendon/ligament bone anchor, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4495 FDA UDI
888.3040 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

Dimensions & Sizes

Size: Length — 4.5 Millimeter FDA UDI
Outer Diameter — 3 Millimeter FDA UDI

Category: Tendon/ligament bone anchor, non-bioabsorbable

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 8e342132-b741-4037-aad3-af0e366c7ece 37 fields · synced May 30, 2026