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TRACKER Plus Kyphoplasty System

by GS Medical Co., Ltd.

510(k) K211797

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 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08800104089473 UDI-DI Date24 Oct 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK211797 Date28 Oct 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k) · GUDID

Generic Name
Balloon kyphoplasty kit
Model / Ref / Catalog
GCD-N1500
Primary DI / UDI-DI
08800104089473
510(k) Number
FDA Product Code
NDN, HRX
GMDN Term
Balloon kyphoplasty kit
Device Class
Class II
Regulation
21 CFR Part 888.3027 510(k)GUDID
888.1100 GUDID
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (9)

  • Implantable: 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