The following data is part of a premarket notification filed by Implanet S.a. with the FDA for Implanet Spine System (iss).
| Device ID | K143731 |
| 510k Number | K143731 |
| Device Name: | IMPLANET Spine System (ISS) |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | IMPLANET S.A. TECHNOPOLE BORDEAUX MONTESQUIEU ALLEE FRANCOIS MAGENDIE Martillac, FR 33650 |
| Contact | Regis Le Couedic |
| Correspondent | Janice M Hogan HOGAN LOVELLS US, L.L.P. 1835 MARKET STREET 29TH FLOOR Philadelphia, PA 19103 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | OSH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-29 |
| Decision Date | 2015-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03607503502429 | K143731 | 000 |
| 03607503502320 | K143731 | 000 |
| 03607503502337 | K143731 | 000 |
| 03607503502344 | K143731 | 000 |
| 03607503502351 | K143731 | 000 |
| 03607503502368 | K143731 | 000 |
| 03607503502375 | K143731 | 000 |
| 03607503502382 | K143731 | 000 |
| 03607503502399 | K143731 | 000 |
| 03607503502405 | K143731 | 000 |
| 03607503502412 | K143731 | 000 |
| 03607503502313 | K143731 | 000 |