K103248 is an FDA 510(k) clearance for the INTEGRITY SPINAL CARE SYSTEM. This device is classified as a Equipment, Traction, Powered (Class II - Special Controls, product code ITH).
Submitted by Integra Life Sciences (Las Vegas, US). The FDA issued a Cleared decision on April 5, 2011, 153 days after receiving the submission on November 3, 2010.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5900.
| 510(k) Number | K103248 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 2010 |
| Decision Date | April 05, 2011 |
| Days to Decision | 153 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | ITH — Equipment, Traction, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5900 |