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Hoffmann

FDA UDI

Class II (US FDA UDI)

by Stryker Corp.

Identity

Trade Name
HOFFMANN FDA UDI
Generic Name
External orthopaedic fixation system, single-use FDA UDI
Device Name
LRF Hexapod Strut - Extra Short - Length 89-109mm FDA UDI
Model / Reference
4935-0-010 FDA UDI
Description
LRF Hexapod Strut - Extra Short - Length 89-109mm FDA UDI

Identifiers

Catalog Number
4935-0-010 FDA UDI
Primary DI / UDI-DI
07613327294255 FDA UDI
510(k) Number
K163656 FDA UDI
K233741 FDA UDI
FDA Product Code
KTT FDA UDI
GMDN Term
External orthopaedic fixation system, single-use 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

No

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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: External orthopaedic fixation system, single-use

Hoffmann by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K163656 also covers:

K233741 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Corp.

Sources (1)

  • FDA UDI 395b5a49-e2c3-44df-94ca-8e6e0a6cbe87 35 fields · synced Jun 6, 2026