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HammerLock

FDA UDI

Class II (US FDA UDI)

by Biomedical Enterprises, Inc.

Identity

Trade Name
HammerLock FDA UDI
Generic Name
Phalangeal joint arthrodesis implant FDA UDI
Device Name
Hammerlock Angled X-Type Medium 19 FDA UDI
Model / Reference
HLXMA FDA UDI
Description
Hammerlock Angled X-Type Medium 19 FDA UDI

Identifiers

Primary DI / UDI-DI
00810633020043 FDA UDI
FDA Product Code
HTY FDA UDI
GMDN Term
Phalangeal joint arthrodesis implant 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

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Angle — 10 degree FDA UDI
Length — 19 Millimeter FDA UDI

Category: Phalangeal joint arthrodesis implant

HammerLock by Biomedical Enterprises, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Phalangeal joint arthrodesis implant.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomedical Enterprises, Inc.

Sources (1)

  • FDA UDI 16f951f1-73f3-4510-8749-6cde88b0b53d 36 fields · synced May 30, 2026