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AnyPlus Spinal Fixation System 2921-7035

by GS Medical Co., Ltd.

AnyPlus Spinal Fixation System 2921-7035 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 28 Jun 2016 (UDI-DI 08806395427758), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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 Number08806395427758 UDI-DI Date28 Jun 2016ListedStatusListed GUDID: not 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 08806395427758 listed 28 Jun 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K091717
  2. Listed FDA GUDID 08806395427758

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  • Withdrawn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
2921-7035
Primary DI / UDI-DI
08806395427758
510(k) Number
FDA product code
KWQ, KWP, NKB, MNI, MNH
GMDN term
Bone-screw internal spinal fixation system, non-sterile
Device class
Class II
Regulation number
888.3060, 888.3050, 888.3070
GUDID distribution status
Not in Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K091717)

and 8 more cleared under K091717

Similar devices

Other devices filed under FDA product code KWQ (Appliance, Fixation, Spinal Intervertebral Body).

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
  • Serial number
Other properties (10, all answered No)