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Dfs Ha Bone Screws

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name
DFS HA BONE SCREWS FDA UDI
Generic Name
External orthopaedic fixation system, single-use, sterile FDA UDI
Model / Reference
HAB60-20090 FDA UDI

Identifiers

Catalog Number
HAB60-20090 FDA UDI
Primary DI / UDI-DI
00887868104374 FDA UDI
510(k) Number
K081244 FDA UDI
K992367 FDA UDI
FDA Product Code
KTT FDA UDI
HWC 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
888.3040 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

Dfs Ha Bone Screws 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.

Cleared under the same submission

K081244 also covers:

K992367 also covers:

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 971f85c9-d45c-48c7-b017-108ae34b7d1e 36 fields · synced Jun 8, 2026