TenoTac Soft Tissue Fixation System

FDA UDI

Class II (US FDA UDI)

by Paragon 28

Identity

Trade Name: TenoTac Soft Tissue Fixation System FDA UDI
Generic Name: Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
Device Name: TenoTac Male Implant ø8mm x 2.2mm x 10mm Long FDA UDI
Model / Reference: P42-822-0100 FDA UDI
Description: TenoTac Male Implant ø8mm x 2.2mm x 10mm Long FDA UDI

Identifiers

Catalog Number: P42-822-0100 FDA UDI
Primary DI / UDI-DI: 00889795057273 FDA UDI
FDA Product Code: HWC FDA UDI
GMDN Term: Tendon/ligament bone anchor, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Tendon/ligament bone anchor, non-bioabsorbable

TenoTac Soft Tissue Fixation System by Paragon 28 — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Tendon/ligament bone anchor, non-bioabsorbable.

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Power Button Adjustable Loop — RIVERPOINT MEDICAL LLC · Class II
SignaLoc Screw — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
JuggerKnot Soft Anchors — Biomet Orthopedics, Inc. · Class II

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: Paragon 28

Sources (1)

FDA UDI b9f49e9a-81db-48a0-b950-99c433bf7b7c 34 fields · synced Jun 8, 2026