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Maxframe

FDA UDI

Class II (US FDA UDI)

by Synthes (u.s.a.) Lp

Identity

Trade Name
MAXFRAME FDA UDI
Generic Name
External orthopaedic fixation frame calculation software FDA UDI
Device Name
MAXFRAME(TM) SOFTWARE FDA UDI
Model / Reference
03.312.000 FDA UDI
Description
MAXFRAME(TM) SOFTWARE FDA UDI

Identifiers

Catalog Number
03312000 FDA UDI
Primary DI / UDI-DI
10886982260949 FDA UDI
510(k) Number
K161417 FDA UDI
FDA Product Code
OSN FDA UDI
KTT FDA UDI
GMDN Term
External orthopaedic fixation frame calculation software 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

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: External orthopaedic fixation frame calculation software

Maxframe by Synthes (u.s.a.) Lp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External orthopaedic fixation frame calculation software.

Cleared under the same submission

K161417 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Synthes (u.s.a.) Lp

Sources (1)

  • FDA UDI af520905-adf2-4690-be44-2ad5e46b5ddc 36 fields · synced May 30, 2026