Graftcage Acx
FDA 510(k) K053080 · Osteotech, Inc.
510(k) numberK053080
Submission
- Device name
- Graftcage Acx
- Applicant
- Osteotech, Inc.
Eatontown, NJ, US - Received
- November 2, 2005
- Decision date
- December 1, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K082615 | Grafton R II Edbm, Demineralized Bone Matrix Allograft, Resorbable Calcium Salt Bone…MQV · Traditional | 10/16/2008SE |
| K081227 | Plexur MMQV · Traditional | 07/22/2008SE |
| K080511 | Plexur-PMQV · Traditional | 04/21/2008SE |
| K073405 | Plexur MMQV · Traditional | 03/03/2008SE |
| K061982 | Plexur PMBP · Traditional | 02/07/2007SE |
| K051188 | Grafton DBMNUN · Traditional | 01/03/2006SE |
| K051781 | Graftcage TLXMQP · Traditional | 12/16/2005SE |
| K051195 | Grafton DBMMBP · Traditional | 12/16/2005SE |
| K043209 | Viagraf DBM PasteMBP · Traditional | 12/05/2005SE |
| K042707 | Grafton Plus DBM PasteNUN · Traditional | 11/30/2005SE |
Questions and answers
When was Graftcage Acx cleared by the FDA?
Graftcage Acx (K053080) received a 510(k) decision of Substantially Equivalent on December 1, 2005, 29 days after the submission was received.
What is the product code of K053080?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.