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Quantum® Spinal Fixation System 10-ROCKER

by Pioneer Surgical Technology, Inc. GUDID

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00846468021658 UDI-DIDate30 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Quantum® Spinal Fixation System
Generic Name
General internal orthopaedic fixation system implantation kit
Model / Reference
10-ROCKER
Primary DI / UDI-DI
00846468021658
FDA Product Code
LXH
GMDN Term
General internal orthopaedic fixation system implantation kit
Device Class
Class I
Regulation Number
888.4540
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

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Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No