The following data is part of a premarket notification filed by Integra Life Sciences with the FDA for Integrity Spinal Care System.
| Device ID | K103248 |
| 510k Number | K103248 |
| Device Name: | INTEGRITY SPINAL CARE SYSTEM |
| Classification | Equipment, Traction, Powered |
| Applicant | INTEGRA LIFE SCIENCES 5795 SOUTH SANDHILL ROAD SUITE F, Las Vegas, NV 89120 |
| Contact | James J Gibson |
| Product Code | ITH |
| CFR Regulation Number | 890.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-11-03 |
| Decision Date | 2011-04-05 |
| Summary: | summary |