The following data is part of a premarket notification filed by North American Medical Corporation (nam) with the FDA for Spina System.
| Device ID | K002260 |
| 510k Number | K002260 |
| Device Name: | SPINA SYSTEM |
| Classification | Equipment, Traction, Powered |
| Applicant | NORTH AMERICAN MEDICAL CORPORATION (NAM) 6595 ROSWELL RD. STE 811 Atlanta, GA 30328 |
| Contact | Carlos Becerra |
| Correspondent | Carlos Becerra NORTH AMERICAN MEDICAL CORPORATION (NAM) 6595 ROSWELL RD. STE 811 Atlanta, GA 30328 |
| Product Code | ITH |
| CFR Regulation Number | 890.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-25 |
| Decision Date | 2000-08-25 |