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Apache 1

by Genesys Orthopedics Systems LLC 1,000+ 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 NumberM719G41000 UDI-DI Date31 Aug 2015ListedStatusListed 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  • Withdrawn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
Apache
Generic name
Vertebral body prosthesis, non-sterile
Model / Ref / Catalog
1, G4100
Primary DI / UDI-DI
M719G41000
FDA product code
ODP, MQP, MAX
GMDN term
Vertebral body prosthesis, non-sterile
Device class
Class II
Regulation number
888.3080, 888.3060
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Vertebral body prosthesis, non-sterile

Other devices from Genesys Orthopedics Systems LLC

See all devices from Genesys Orthopedics Systems LLC →

Properties

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

Other properties (11)

  • Supplied sterile: No
  • Implantable: 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