Small Stature Spacers
FDA 510(k) K063393 · Biomet Spine
510(k) numberK063393
Submission
- Device name
- Small Stature Spacers
- Applicant
- Biomet Spine
Warsaw, IN, US - Received
- November 9, 2006
- Decision date
- June 25, 2007
- 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 |
|---|---|---|
| K152622 | Alta ACDF SystemOVE · Traditional | 07/08/2016SE |
| K153695 | Biomet Spine Fusion SystemMAX · Special | 01/21/2016SE |
| K151974 | Polaris Spinal SystemNKB · Traditional | 11/13/2015SE |
| K151064 | Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…OVE · Traditional | 08/12/2015SE |
| K151483 | Biomet Spine Fusion SystemMAX · Traditional | 07/31/2015SE |
| K151224 | Lineum OCT Spine SystemNKG · Traditional | 06/30/2015SE |
| K142634 | Biomet Spine Fusion SystemMAX · Traditional | 03/12/2015SE |
| K141791 | Biomet Fusion SystemOVD · Traditional | 10/09/2014SE |
| K141804 | Polaris Spinal System - Ha CoatedNKB · Traditional | 09/25/2014SE |
| K121130 | Polaris Spinal System-Ballista Spinal RodsNKB · Special | 06/15/2012SE |
Questions and answers
When was Small Stature Spacers cleared by the FDA?
Small Stature Spacers (K063393) received a 510(k) decision of Substantially Equivalent on June 25, 2007, 228 days after the submission was received.
What is the product code of K063393?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.