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Binary 1

by Genesys Orthopedics Systems LLC 122 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 NumberM719GCP2AF3160 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  • Withdrawn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
Binary
Generic Name
Spinal fixation plate, non-bioabsorbable
Model / Ref / Catalog
1, GCP2-AF316
Primary DI / UDI-DI
M719GCP2AF3160
FDA Product Code
KWQ
GMDN Term
Spinal fixation plate, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3060
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Length — 16 Millimeter
Outer Diameter — 3.75 Millimeter

Related devices

Category: Spinal fixation plate, non-bioabsorbable

Other devices from Genesys Orthopedics Systems LLC

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Properties

  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number

Other properties (10)

  • 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