K063139 is an FDA 510(k) clearance for the SPINAL STABILIZING SPHERE SYSTEM. This device is classified as a Intervertebral Fusion Device With Bone Graft, Solid-sphere, Lumbar (Class III - Premarket Approval, product code NVR).
Submitted by Biomet Spine (Warsaw, US). The FDA issued a Cleared decision on April 4, 2007, 170 days after receiving the submission on October 16, 2006.
This device falls under the Orthopedic FDA review panel. Intended To Be Inserted Between The Vertebral Bodies Into The Disc Space From L3 To S1 To Provide Stabilization And To Help Promote Intervertebral Body Fusion. To Be Used With Bone Graft, For Holding Bone Parts In Alignment While They Heal. Not Intended For Use In Motion-sparing, Non-fusion Procedures, Helps Promote Intervertebral Body Fusion, Please Reference: Https://www.federalregister.gov/documents/2023/03/30/2023-06566/medical-devices-orthopedic-devices-classification-of-spinal-spheres-for-use-in-intervertebral-fusion..
| 510(k) Number | K063139 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | October 16, 2006 |
| Decision Date | April 04, 2007 |
| Days to Decision | 170 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | NVR — Intervertebral Fusion Device With Bone Graft, Solid-sphere, Lumbar |
| Device Class | Class III - Premarket Approval |
| Definition | Intended To Be Inserted Between The Vertebral Bodies Into The Disc Space From L3 To S1 To Provide Stabilization And To Help Promote Intervertebral Body Fusion. To Be Used With Bone Graft, For Holding Bone Parts In Alignment While They Heal. Not Intended For Use In Motion-sparing, Non-fusion Procedures, Helps Promote Intervertebral Body Fusion, Please Reference: Https://www.federalregister.gov/documents/2023/03/30/2023-06566/medical-devices-orthopedic-devices-classification-of-spinal-spheres-for-use-in-intervertebral-fusion. |