VersaPEEK

FDA UDI

Class II (US FDA UDI)

by Ortho-Design (pty) Ltd

Identity

Trade Name: VersaPEEK FDA UDI
Generic Name: Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
Device Name: VersaPEEK™, PEEK Suture Anchor, 4.5 x 15mm, w/Needles, 2 Sutures FDA UDI
Model / Reference: APP002-N FDA UDI
Description: VersaPEEK™, PEEK Suture Anchor, 4.5 x 15mm, w/Needles, 2 Sutures FDA UDI

Identifiers

Catalog Number: APP002-N FDA UDI
Primary DI / UDI-DI: 06009712642267 FDA UDI
510(k) Number: K242296 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

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

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Tendon/ligament bone anchor, non-bioabsorbable

VersaPEEK by Ortho-Design (pty) Ltd — 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

Cleared under the same submission

K242296 also covers:

VersaPEEK — ORTHO-DESIGN (PTY) LTD

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: Ortho-Design (pty) Ltd

Sources (1)

FDA UDI 9c21d9d3-541a-4219-930c-779081a101a0 35 fields · synced May 30, 2026