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ION Non Cervical SR17-1000

by Surgentec LLC GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810131885045 UDI-DIDate28 Jul 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
ION Non Cervical
Generic Name
Facet joint prosthesis
Model / Reference
SR17-1000
Primary DI / UDI-DI
00810131885045
510(k) Number
FDA Product Code
MRW, FMF, HTR
GMDN Term
Facet joint prosthesis
Device Class
U
Regulation Number
880.5860, 878.4800
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K243265)

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Cleared under the same submission (K261209)

Other devices from Surgentec LLC

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Properties

  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: 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