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The Brachiator Mini External Fixation System P46-100-0040

by Paragon 28

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number00889795151841 UDI-DI Date16 Dec 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
The Brachiator Mini External Fixation System
Generic Name
External orthopaedic fixation system noninvasive component, single-use
Model / Ref / Catalog
P46-100-0040
Primary DI / UDI-DI
00889795151841
510(k) Number
FDA Product Code
KTT
GMDN Term
External orthopaedic fixation system noninvasive component, single-use
Device Class
Class II
Regulation Number
888.3030
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K252106)

Show all (12)

Other devices from Paragon 28

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No