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ASTRA Spine System A5R-55FL-075K

by Spinecraft LLC 2 variants

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00193082055256 UDI-DI Date14 Feb 2019ListedStatusListed GUDID: 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  • Withdrawn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
ASTRA Spine System
Generic name
Bone-screw internal spinal fixation system rod
Model / Ref / Catalog
A5R-55FL-075K
Primary DI / UDI-DI
00193082055256
FDA product code
KWQ, MNH, MNI, NKB, KWP
GMDN term
Bone-screw internal spinal fixation system rod
Device class
Class II
Regulation number
888.3060, 888.3070, 888.3050
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Bone-screw internal spinal fixation system rod

Other devices from Spinecraft LLC

See all devices from Spinecraft LLC →

Properties

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

Other properties (10)

  • Supplied sterile: 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