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AnyPlus Spinal Fixation System 0902-7565

by GS Medical Co., Ltd.

AnyPlus Spinal Fixation System 0902-7565 is a Class II device made by GS Medical Co., Ltd., cleared under FDA 510(k) K091717 on 25 Jan 2010 and listed in FDA GUDID since 3 Jul 2023 (UDI-DI 08809885732868), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K091717

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08809885732868 UDI-DI Date3 Jul 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK091717 Date25 Jan 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K091717 decided 25 Jan 2010 Active
  • FDA GUDID UDI-DI 08809885732868 listed 3 Jul 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K091717
  2. Listed FDA GUDID 08809885732868

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AnyPlus Spinal Fixation System
Generic name
Bone-screw internal spinal fixation system, non-sterile
Model / Ref / Catalog
0902-7565
Primary DI / UDI-DI
08809885732868
510(k) Number
FDA product code
NKB, KWP, KWQ, MNH, MNI
GMDN term
Bone-screw internal spinal fixation system, non-sterile
Device class
Class II
Regulation number
888.3070, 888.3050, 888.3060
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Bone-screw internal spinal fixation system, non-sterile

Cleared under the same submission (K091717)

and 8 more cleared under K091717

Similar devices

Other devices filed under FDA product code NKB (Thoracolumbosacral Pedicle Screw System).

Other devices from GS Medical Co., Ltd.

See all devices from GS Medical Co., Ltd. →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)