The following data is part of a premarket notification filed by Implanet S.a. with the FDA for Implanet Spine System.
| Device ID | K132303 |
| 510k Number | K132303 |
| Device Name: | IMPLANET SPINE SYSTEM |
| Classification | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| Applicant | IMPLANET S.A. 1835 MARKET ST. 29TH FLOOR Philadelphia, PA 19103 |
| Contact | Janice M Hogan |
| Correspondent | Janice M Hogan IMPLANET S.A. 1835 MARKET ST. 29TH FLOOR Philadelphia, PA 19103 |
| Product Code | OSH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-24 |
| Decision Date | 2013-10-10 |
| Summary: | summary |