The following data is part of a premarket notification filed by North American Medical Corp (nam) with the FDA for Spina System.
| Device ID | K033231 |
| 510k Number | K033231 |
| Device Name: | SPINA SYSTEM |
| Classification | Equipment, Traction, Powered |
| Applicant | NORTH AMERICAN MEDICAL CORP (NAM) 3350 RIVERWOOD PKWY. SUITE 1900 Atlanta, GA 30339 |
| Contact | Gidgette Rubin |
| Correspondent | Gidgette Rubin NORTH AMERICAN MEDICAL CORP (NAM) 3350 RIVERWOOD PKWY. SUITE 1900 Atlanta, GA 30339 |
| Product Code | ITH |
| CFR Regulation Number | 890.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-06 |
| Decision Date | 2005-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00869444000218 | K033231 | 000 |