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FacetFuse® 01-00007-SW5560

by Spinefrontier, Inc.

FacetFuse® 01-00007-SW5560 is a device classified as Unclassified made by Spinefrontier, Inc., cleared under FDA 510(k) K071420 on 16 Jan 2008 and listed in FDA GUDID since 15 Apr 2016 (UDI-DI 00190361016847), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K071420

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00190361016847 UDI-DI Date15 Apr 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK071420 Date16 Jan 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K071420 decided 16 Jan 2008 Active
  • FDA GUDID UDI-DI 00190361016847 listed 15 Apr 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1871-2013 FDA Class II initiated 9 Nov 2012 on shared 510(k) K071420

    Prior to use in surgery, the Drill Guides were presenting noticeable degrees of denting and/or bending. As a result, drills and taps could not be directed down guides during surgery due to mechanical interference.

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

Timeline

3 dated events

  1. Cleared FDA 510(k) K071420
  2. Recall initiated FDA recalls Z-1871-2013
  3. Listed FDA GUDID 00190361016847

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
FacetFuse®
Generic name
Trans-facet-screw internal spinal fixation system, sterile
Model / reference
01-00007-SW5560
Primary DI / UDI-DI
00190361016847
510(k) Number
FDA product code
MRW
GMDN term
Trans-facet-screw internal spinal fixation system, sterile
Device class
U
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 60 Millimeter
Outer Diameter — 5.5 Millimeter

Related devices

Category: Trans-facet-screw internal spinal fixation system, sterile

Cleared under the same submission (K071420)

and 8 more cleared under K071420

Other devices from Spinefrontier, Inc.

See all devices from Spinefrontier, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (11, all answered No)