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SOLOFIX Provisional Fixation System 500-103

by Axia Orthopedics

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850083430078 UDI-DI Date17 Aug 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
SOLOFIX Provisional Fixation System
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable
Model / Reference
500-103
Primary DI / UDI-DI
00850083430078
FDA Product Code
HWN
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device Class
Class I
Regulation Number
888.4540
GUDID distribution status
In Commercial Distribution
Size
Length — 115 Millimeter
Width — 78 Millimeter

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Properties

  • Sterile
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No