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Tops 2 - 21 M 88943

by Premia Spine Ltd GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290115935356 UDI-DIDate9 Jul 2026ListedStatusListed GUDID: 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  • Withdrawn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 22 Oct 2026.

Specification

GUDID

Trade Name
Tops 2 - 21 M
Generic Name
Posterior lumbar spine prosthesis
Model / Reference
88943
Primary DI / UDI-DI
07290115935356
FDA Product Code
QWK
GMDN Term
Posterior lumbar spine prosthesis
Device Class
Class III
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Other devices from Premia Spine Ltd

See all devices from Premia Spine Ltd →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (6)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No