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GSS Pedicle Screw System GS0101-9570

by GS Medical Co., Ltd.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number08806162172980 UDI-DI Date21 Apr 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
GSS Pedicle Screw System
Generic Name
Bone-screw internal spinal fixation system, non-sterile
Model / Ref / Catalog
GS0101-9570
Primary DI / UDI-DI
08806162172980
510(k) Number
FDA Product Code
MNH, MNI
GMDN Term
Bone-screw internal spinal fixation system, non-sterile
Device Class
Class II
Regulation Number
888.3070
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K053573)

Show all (12)

Other devices from GS Medical Co., Ltd.

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Properties

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

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No
  • Manufacturing Date: No