The following data is part of a premarket notification filed by Orthotec, Inc. with the FDA for Scs Spinal System.
| Device ID | K983353 |
| 510k Number | K983353 |
| Device Name: | SCS SPINAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | ORTHOTEC, INC. 200 GREGORY LN. SUITE C - 100 Pleasant Hill, CA 94523 -3389 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf ORTHOTEC, INC. 200 GREGORY LN. SUITE C - 100 Pleasant Hill, CA 94523 -3389 |
| Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-23 |
| Decision Date | 1998-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840996123099 | K983353 | 000 |
| 00840996122351 | K983353 | 000 |
| 00840996122344 | K983353 | 000 |
| 00840996122337 | K983353 | 000 |
| 00840996122320 | K983353 | 000 |
| 00840996122313 | K983353 | 000 |
| 00840996122306 | K983353 | 000 |
| 00840996122290 | K983353 | 000 |
| 00840996122283 | K983353 | 000 |
| 00840996122276 | K983353 | 000 |
| 00840996122269 | K983353 | 000 |
| 00840996122252 | K983353 | 000 |
| 00840996122245 | K983353 | 000 |
| 00840996122238 | K983353 | 000 |
| 00840996122221 | K983353 | 000 |
| 00840996122214 | K983353 | 000 |
| 00840996122207 | K983353 | 000 |
| 00840996122368 | K983353 | 000 |
| 00840996122375 | K983353 | 000 |
| 00840996122382 | K983353 | 000 |
| 00840996122986 | K983353 | 000 |
| 00840996122979 | K983353 | 000 |
| 00840996122962 | K983353 | 000 |
| 00840996122849 | K983353 | 000 |
| 00840996122832 | K983353 | 000 |
| 00840996122788 | K983353 | 000 |
| 00840996122504 | K983353 | 000 |
| 00840996122481 | K983353 | 000 |
| 00840996122474 | K983353 | 000 |
| 00840996122467 | K983353 | 000 |
| 00840996122450 | K983353 | 000 |
| 00840996122443 | K983353 | 000 |
| 00840996122436 | K983353 | 000 |
| 00840996122429 | K983353 | 000 |
| 00840996122405 | K983353 | 000 |
| 00840996122399 | K983353 | 000 |
| 00840996122191 | K983353 | 000 |