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Hoffman Classic™wrist Fixator

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name
HOFFMAN CLASSIC™WRIST FIXATOR FDA UDI
Generic Name
External orthopaedic fixation system, single-use, sterile FDA UDI
Model / Reference
8082-00-000 FDA UDI

Identifiers

Catalog Number
808200000 FDA UDI
Primary DI / UDI-DI
00887868034657 FDA UDI
510(k) Number
K003397 FDA UDI
K013503 FDA UDI
FDA Product Code
KTT FDA UDI
GMDN Term
External orthopaedic fixation system, single-use, sterile 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

Category: External orthopaedic fixation system, single-use, sterile

Hoffman Classic™wrist Fixator by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External orthopaedic fixation system, single-use, sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomet Orthopedics, Inc.

Sources (1)

  • FDA UDI 537af5a2-2801-4dbd-9eaf-3deb6d3cc05c 35 fields · synced May 30, 2026