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Polaris 5.5 Spinal Fixation System 14-500130E

by Highridge Medical, LLC GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03662663132039 UDI-DIDate14 Nov 2025ListedStatusListed 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  • Withdrawn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
Polaris 5.5 Spinal Fixation System
Generic Name
Bone-screw internal spinal fixation system connector
Model / Ref / Catalog
14-500130E
Primary DI / UDI-DI
03662663132039
FDA Product Code
NKB
GMDN Term
Bone-screw internal spinal fixation system connector
Device Class
Class II
Regulation Number
888.3070
GUDID distribution status
In Commercial Distribution

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Properties

  • Sterile
  • Implantable

Other properties (12)

  • Single Use: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No