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CAPSTONE PTC™ Spinal System 3993616

by Medtronic Sofamor Danek, Inc.

CAPSTONE PTC™ Spinal System 3993616 is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K172199 on 19 Sep 2017 (1 earlier submission) and listed in FDA GUDID since 17 Apr 2016 (UDI-DI 00643169187160), active as of 22 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 22 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK172199 Date19 Sep 2017DecidedStatusActive
United StatesGUDID listing Number00643169187160 UDI-DI Date17 Apr 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K172199 decided 19 Sep 2017 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00643169187160 listed 17 Apr 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K133205
  2. Listed FDA GUDID 00643169187160
  3. Cleared FDA 510(k) K172199

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
CAPSTONE PTC™ Spinal System
Generic name
Polymeric spinal interbody fusion cage
Model / reference
3993616
Primary DI / UDI-DI
00643169187160
510(k) Number
FDA product code
MAX
GMDN term
Polymeric spinal interbody fusion cage
Device class
Class II
Regulation number
888.3080
GUDID distribution status
In Commercial Distribution

Related devices

Category: Polymeric spinal interbody fusion cage

Cleared under the same submission (K133205)

and 8 more cleared under K133205

Cleared under the same submission (K172199)

and 8 more cleared under K172199

Similar devices

Other devices filed under FDA product code MAX (Intervertebral fusion device with bone graft, lumbar).

Other devices from Medtronic Sofamor Danek, Inc.

See all devices from Medtronic Sofamor Danek, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Lot / batch number
Other properties (11, all answered No)