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ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System 1

by Orthofix, Inc. 3 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number18054242515432 UDI-DI Date18 Apr 2018ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
Generic Name
External orthopaedic fixation system noninvasive component, reprocessed
Model / Ref / Catalog
1, 193110
Primary DI / UDI-DI
18054242515432
510(k) Number
FDA Product Code
HSB
GMDN Term
External orthopaedic fixation system noninvasive component, reprocessed
Device Class
Class II
Regulation Number
888.3020
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: External orthopaedic fixation system, single-use

Cleared under the same submission (K161466)

Show all (12)

Other devices from Orthofix, Inc.

See all devices from Orthofix, Inc. →

Properties

  • Lot / Batch Number
  • Manufacturing Date

Other properties (12)

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