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Maxframe

FDA UDI

Class II (US FDA UDI)

by Synthes

Identity

Trade Name
MAXFRAME FDA UDI
Generic Name
External orthopaedic fixation system, single-use FDA UDI
Device Name
MAXFRAME AUTOSTRUT(TM) HEXAPOD STRUT - MED/ STERILE FDA UDI
Model / Reference
03.314.813S FDA UDI
Description
MAXFRAME AUTOSTRUT(TM) HEXAPOD STRUT - MED/ STERILE FDA UDI

Identifiers

Catalog Number
03314813S FDA UDI
Primary DI / UDI-DI
10886982343727 FDA UDI
510(k) Number
K231922 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

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

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
MRI Safety
MR Unsafe FDA UDI

Category: External orthopaedic fixation system, single-use

Maxframe by Synthes — 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

K231922 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Synthes

Sources (1)

  • FDA UDI 8f979941-cc6e-4eec-9676-00bf2a63235b 36 fields · synced May 30, 2026