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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(TM) MULTI PARALLEL PIN MOUNT POST 3 HIGH FDA UDI
Model / Reference
03.313.859 FDA UDI
Description
MAXFRAME(TM) MULTI PARALLEL PIN MOUNT POST 3 HIGH FDA UDI

Identifiers

Catalog Number
03313859 FDA UDI
Primary DI / UDI-DI
10886982306357 FDA UDI
510(k) Number
K051600 FDA UDI
K092190 FDA UDI
K161417 FDA UDI
FDA Product Code
OSN FDA UDI
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 Conditional 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

K051600 also covers:

K092190 also covers:

K161417 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 1f0353ee-b212-4665-ba26-166061b74775 36 fields · synced May 30, 2026