The following data is part of a premarket notification filed by Integrity Life Sciences with the FDA for Integrity Spinal Care System 3.0.
| Device ID | K130249 |
| 510k Number | K130249 |
| Device Name: | INTEGRITY SPINAL CARE SYSTEM 3.0 |
| Classification | Equipment, Traction, Powered |
| Applicant | INTEGRITY LIFE SCIENCES 2189 WEST BUSCH BLVD Tampa, FL 33612 |
| Contact | James J Gibson |
| Correspondent | James J Gibson INTEGRITY LIFE SCIENCES 2189 WEST BUSCH BLVD Tampa, FL 33612 |
| Product Code | ITH |
| CFR Regulation Number | 890.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-01 |
| Decision Date | 2014-02-06 |
| Summary: | summary |