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Firebird 77-7811

by Orthofix US LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

3 closed

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 Number18257200020621 UDI-DI Date24 Sep 2014ListedStatusListed GUDID: in commercial distribution

Recalls

3 recalls · FDA

    • Terminated Z-0855-2014 FDA Class II initiated 26 Nov 2013 on shared 510(k) K081684

    Orthofix received 6 complaints which resulted in a reportable events due to extended surgical times greater than 30 minutes for the Modular Screw Driver (PN 52-1332). The complaints alleged that the screw driver's collet would malfunction resulting in the surgeon being unable to use the Modular Screw Driver to effectively place Modular Screws, which may result in a delay of surgery.

    • Terminated Z-1674-2011 FDA Unclassified (pre-2012) initiated 22 Oct 2010

    There is a possibility that certain Multi-Axial Screws have spherical heads measuring less than the allowable tolerance.

    • Terminated Z-1608-2011 FDA Unclassified (pre-2012) initiated 22 Oct 2010

    There is a possibility that certain Anti-Splay Caps may not mate properly during assembly of the construct to the Screw Body with Multi-Axial Reduction Screw Assemblies.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Firebird
Generic Name
Bone-screw internal spinal fixation system
Model / Reference
77-7811
Primary DI / UDI-DI
18257200020621
510(k) Number
FDA Product Code
NKB
GMDN Term
Bone-screw internal spinal fixation system
Device Class
Class II
Regulation Number
888.3070
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 8.5 Millimeter
Length — 110 Millimeter

Related devices

Category: Bone-screw internal spinal fixation system

Cleared under the same submission (K081684)

Show all (12)

Other devices from Orthofix US LLC

See all devices from Orthofix US LLC →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (11)

  • 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
  • Expiration Date: No
  • Manufacturing Date: No