Modification to Telescopic Plate Spacer Thoracolumbar (Tps-Tl) Spinal System, Model 8130, 8131
FDA 510(k) K014145 · Interpore Cross Intl.
510(k) numberK014145
Submission
- Device name
- Modification to Telescopic Plate Spacer Thoracolumbar (Tps-Tl) Spinal System, Model 8130, 8131
- Applicant
- Interpore Cross Intl.
Irvine, CA, US - Received
- December 18, 2001
- Decision date
- January 17, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQP – Spinal Vertebral Body Replacement Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MQP
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|---|---|---|---|
| K261810 | Vertiwedge® Intraosseous SystemMQP · Special | Foundation Surgical Group | 07/31/2026SE |
| K261031 | Poseidon STMQP · Traditional | Signus Medinzintechnik GmbH | 07/10/2026SE |
| K253158 | VyBrate VBR SystemMQP · Traditional | Vy Spine, LLC | 01/07/2026SE |
| K241468 | Vertiwedge® Intraosseous SystemMQP · Traditional | Foundation Surgical Group, Inc. | 11/07/2024SE |
| K232790 | KONG®-TL VBR System and KONG® C VBR SystemMQP · Traditional | Icotec AG | 04/04/2024SE |
| K233359 | DOMINION Expandable Corpectomy SystemMQP · Traditional | Astura Medical | 03/08/2024SE |
| K231134 | VerteLoc Spinal SystemMQP · Traditional | Signature Orthopaedics Pty, Ltd. | 02/13/2024SE |
| K232173 | Ascend VBR System, Ascend NanoTec VBR SystemMQP · Traditional | Alphatec Spine, Inc. | 10/06/2023SE |
| K211892 | ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)MQP · Traditional | Arftx Medical, LLC | 10/06/2022SE |
| K202637 | F3D Corpectomy SystemMQP · Traditional | Corelink, LLC | 12/23/2020SE |
More from Corelink, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K050861 | PEEK CasMQP · Special | 05/27/2005SE |
| K031399 | Intergro DBMMQV · Traditional | 02/18/2005SE |
| K041407 | Titanium Mesh ImplantMQP · Traditional | 12/29/2004SE |
| K043229 | Modification to Altius Oct SystemKWP · Special | 12/21/2004SE |
| K042798 | C-Tek C-Trun Anterior Cervical Plate SystemKWQ · Special | 11/04/2004SE |
| K040928 | Expandable PEEK VBR ImplantMQP · Traditional | 08/27/2004SE |
| K041794 | C-Tek C-Thru Anterior Cervical Plate SystemKWQ · Special | 07/19/2004SE |
| K041449 | Synergy Helical Flange Plug, Helical Flange Seat and Helical Flange Reduction SeatKWP · Special | 07/01/2004SE |
| K033961 | Altius Oct SystemKWP · Special | 04/14/2004SE |
| K040168 | Modification to Geo StructureMQP · Special | 04/08/2004SE |
Questions and answers
When was Modification to Telescopic Plate Spacer Thoracolumbar (Tps-Tl) Spinal System, Model 8130, 8131 cleared by the FDA?
Modification to Telescopic Plate Spacer Thoracolumbar (Tps-Tl) Spinal System, Model 8130, 8131 (K014145) received a 510(k) decision of Substantially Equivalent on January 17, 2002, 30 days after the submission was received.
What is the product code of K014145?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.