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Spine Wave Instruments 10-0205

by Spine Wave, Inc.

Spine Wave Instruments 10-0205 is a Class I device made by Spine Wave, Inc., listed in FDA GUDID since 21 Oct 2026 (UDI-DI 10840642182149), registry data as of 2 Nov 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 2 Nov 2026.

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10840642182149 UDI-DI Date21 Oct 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  • Withdrawn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
Spine Wave Instruments
Generic name
Spinal rongeur
Model / Ref / Catalog
10-0205
Primary DI / UDI-DI
10840642182149
FDA product code
HTX
GMDN term
Spinal rongeur
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from Spine Wave, Inc.

See all devices from Spine Wave, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (11, all answered No)