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Unison™-C Anterior Cervical Fixation System 63-SCREWEXTRACTOR

by Pioneer Surgical Technology Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 8 Nov 2026. What this means

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00846468077020 UDI-DI Date28 Jan 2016ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Unison™-C Anterior Cervical Fixation System
Generic name
General internal orthopaedic fixation system implantation kit
Model / reference
63-SCREWEXTRACTOR
Primary DI / UDI-DI
00846468077020
FDA product code
OVE
GMDN term
General internal orthopaedic fixation system implantation kit
Device class
Class II
Regulation number
888.3080
GUDID distribution status
Not in Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

From the manufacturer

Manufacturer's product page: OEM-ready PlatformsAnterior Cervical Plating System

Other devices from Pioneer Surgical Technology Inc.

See all devices from Pioneer Surgical Technology Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number

Other properties (12)

  • Supplied sterile: No
  • Single use: 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