K073105 is an FDA 510(k) clearance for the PEEK SPINAL SPHERES. This device is classified as a Intervertebral Fusion Device With Bone Graft, Solid-sphere, Lumbar (Class III - Premarket Approval, product code NVR).
Submitted by Interbody Innovations, Llp (Round Rock, US). The FDA issued a Cleared decision on January 3, 2008, 62 days after receiving the submission on November 2, 2007.
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 | K073105 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | November 02, 2007 |
| Decision Date | January 03, 2008 |
| Days to Decision | 62 days |
| Submission Type | Special |
| 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. |