Fastin Ethibond

FDA UDI

Class II (US FDA UDI)

by DePuy Mitek, Inc.

Identity

Trade Name: FASTIN ETHIBOND FDA UDI
Generic Name: Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
Device Name: FASTIN ANCHOR Size 2 (5 metric) green ETHIBOND braided polyester suture, 26 Inches (66cm), Anchor 5.2mm Diameter x 11.5mm long. FDA UDI
Model / Reference: 222152 FDA UDI
Description: FASTIN ANCHOR Size 2 (5 metric) green ETHIBOND braided polyester suture, 26 Inches (66cm), Anchor 5.2mm Diameter x 11.5mm long. FDA UDI

Identifiers

Catalog Number: 222152 FDA UDI
Primary DI / UDI-DI: 10886705007516 FDA UDI
510(k) Number: K945203 FDA UDI
FDA Product Code: JDR FDA UDI
GMDN Term: Tendon/ligament bone anchor, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 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 Conditional FDA UDI

Category: Tendon/ligament bone anchor, non-bioabsorbable

Fastin Ethibond by DePuy Mitek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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SignaLoc Screw — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
JuggerKnot Soft Anchors — Biomet Orthopedics, Inc. · Class II
OrthoButton AL — RIVERPOINT MEDICAL LLC · Class II

Cleared under the same submission

K945203 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: DePuy Mitek, Inc.

Sources (1)

FDA UDI 61632b5b-fbf3-40ea-84fb-522ae2bed8e6 37 fields · synced Jun 1, 2026