CAPSTONE PTC™ Spinal System 3992209

• FDA 510(k) K172199 decided 19 Sep 2017 Active· +1 more in the status table
• FDA GUDID UDI-DI 00643169187542 listed 17 Apr 2016 Listed

1. 13 Mar 2014 Cleared FDA 510(k) K133205
2. 17 Apr 2016 Listed FDA GUDID 00643169187542
3. 19 Sep 2017 Cleared FDA 510(k) K172199

Trade name

CAPSTONE PTC™ Spinal System

Generic name

Polymeric spinal interbody fusion cage

Model / reference

3992209

Primary DI / UDI-DI

00643169187542

510(k) Number

K133205 ↗

K172199 ↗

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

Category: Polymeric spinal interbody fusion cage

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

• Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System by ALPHATEC SPINE, INC.
• Cortina MAX Lumbar Cage System by NEUROSTRUCTURES, INC
• Abacus Spacer System by Spine Wave, Inc.
• Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL by Titan Spine, Inc.
• Medussa-PL Cage by Medyssey USA, Inc.
• Apache Lateral Lumbar Interbody Fusion System by Genesys Spine
• Half Dome Posterior Lumbar Interbody System by Astura Medical
• Altus Spine Interbody Fusion System by Altus Partners
• JULIET ® Ti LL JLT-M0 50 14-S by Spineart
• CONCORDE 196923509 by MEDOS INTERNATIONAL SARL

• MSB Reusable Instruments 9870005

  Class I

  GUDID on market

• MSB CD HORIZON Spinal System 6530530

  Class II

  FDA 510(k) K170679 Active Cleared 11 May 2017 GUDID on market

• T2 STRATOSPHERE™ Expandable Corpectomy System 436125C

  Class II

  FDA 510(k) K183510 Active Cleared 16 Jan 2019 GUDID on market

• MSB SHILLA Growth Guidance System 7670431

  Class II

  FDA 510(k) K140750 Active Cleared 17 Jul 2014 GUDID on market

See all devices from Medtronic Sofamor Danek, Inc. →