The following data is part of a premarket notification filed by Cert Health Sciences, Llc with the FDA for Spinemed S200b/s200c.
| Device ID | K051013 |
| 510k Number | K051013 |
| Device Name: | SPINEMED S200B/S200C |
| Classification | Equipment, Traction, Powered |
| Applicant | CERT HEALTH SCIENCES, LLC 10440 LITTLE PATUXENT PARKWAY SUITE 300 Columbia, MD 21044 |
| Contact | Tim R Emsky |
| Correspondent | Tamas Borsai TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | ITH |
| CFR Regulation Number | 890.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-04-21 |
| Decision Date | 2005-04-27 |
| Summary: | summary |