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Falcon 907001-0800

by Responsive Orthopedics LLC

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00811714034850 UDI-DI Date16 Mar 2022ListedStatusListed 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  • Withdrawn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
Falcon
Generic name
Bone-resection orthopaedic reamer, single-use
Model / reference
907001-0800
Primary DI / UDI-DI
00811714034850
FDA product code
LXH
GMDN term
Bone-resection orthopaedic reamer, single-use
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution

Related devices

Category: Bone-resection orthopaedic reamer, single-use

Other devices from Responsive Orthopedics LLC

See all devices from Responsive Orthopedics LLC →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date

Other properties (8)

  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No