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IMPLANET SPINE SYSTEM Pedicle screw blocker

by Implanet

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 Number03607503500241 UDI-DI Date19 Sep 2014ListedStatusListed 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  • Withdrawn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
Implanet Spine System
Generic Name
Trans-facet-screw internal spinal fixation system, sterile
Model / Ref / Catalog
Pedicle screw blocker, 350024
Primary DI / UDI-DI
03607503500241
510(k) Number
FDA Product Code
OSH, MNH, KWP, NKB, MNI
GMDN Term
Trans-facet-screw internal spinal fixation system, sterile
Device Class
Class II
Regulation Number
888.3070, 888.3050
GUDID distribution status
In Commercial Distribution

Related devices

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

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Cleared under the same submission (K143731)

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Properties

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

Other properties (10)

  • 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
  • Manufacturing Date: No