ALLthread PEEK-OPTIMA

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name: ALLthread PEEK-OPTIMA FDA UDI
Generic Name: Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
Model / Reference: 904923P FDA UDI

Identifiers

Catalog Number: 904923P FDA UDI
Primary DI / UDI-DI: 00880304507081 FDA UDI
FDA Product Code: JDR FDA UDI
HWC FDA UDI
MBI FDA UDI
MAI 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
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

FDA UDI

Category: Tendon/ligament bone anchor, non-bioabsorbable

ALLthread PEEK-OPTIMA by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Biomet Orthopedics, Inc.

Sources (1)

FDA UDI 9eaad88c-eb49-4240-8aef-5ba45eafdfee 35 fields · synced May 30, 2026