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Tops 2 - 38 L 88948

by Premia Spine Ltd

Tops 2 - 38 L 88948 is a Class III device made by Premia Spine Ltd, listed in FDA GUDID since 9 Jul 2026 (UDI-DI 07290115935424), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290115935424 UDI-DI Date9 Jul 2026ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Tops 2 - 38 L
Generic name
Posterior lumbar spine prosthesis
Model / reference
88948
Primary DI / UDI-DI
07290115935424
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

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (7, all answered No)