K100802 is an FDA 510(k) clearance for the AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM. This device is classified as a Intervertebral Fusion Device With Integrated Fixation, Lumbar (Class II - Special Controls, product code OVD).
Submitted by Aesculap Implant Systems, Inc. (Center Valley, US). The FDA issued a Cleared decision on July 20, 2010, 120 days after receiving the submission on March 22, 2010.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3080. Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation..
| 510(k) Number | K100802 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 2010 |
| Decision Date | July 20, 2010 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OVD — Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3080 |
| Definition | Intended To Stabilize Lumbar Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation. |