OsteoFab Suture Anchor

FDA UDI

Class II (US FDA UDI)

by Oxford Performance Materials

Identity

Trade Name: OsteoFab Suture Anchor FDA UDI
Generic Name: Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
Device Name: OsteoFab 5.5mm Suture Anchor FDA UDI
Model / Reference: SA002-55 FDA UDI
Description: OsteoFab 5.5mm Suture Anchor FDA UDI

Identifiers

Primary DI / UDI-DI: 00850004435052 FDA UDI
510(k) Number: K190915 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

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 Safe FDA UDI

Category: Tendon/ligament bone anchor, non-bioabsorbable

OsteoFab Suture Anchor by Oxford Performance Materials — 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

K190915 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: Oxford Performance Materials

Sources (1)

FDA UDI 38b0af36-39a0-4140-b688-09f2b253f66b 35 fields · synced May 30, 2026