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 Inserter, T15 FDA UDI
Model / Reference: P42-901-T154 FDA UDI
Description: TenoTac Male Implant Inserter, T15 FDA UDI

Identifiers

Catalog Number: P42-901-T154 FDA UDI
Primary DI / UDI-DI: 00889795053626 FDA UDI
510(k) Number: K182898 FDA UDI
FDA Product Code: MBI 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

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

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

Similar devices

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

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Ecobone — Bonegraft Biomaterials Co. · Class III
fX — Bonegraft Biomaterials Co. · Class III
GII PANACRYL — DePuy Mitek, Inc. · Class II
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

Cleared under the same submission

K182898 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: Paragon 28

Sources (1)

FDA UDI 65a0c959-36f2-496d-9dbc-387909cb4df4 35 fields · synced May 30, 2026