The following data is part of a premarket notification filed by Neo Medical S.a. with the FDA for Neo Pedicle Screw System™.
| Device ID | K171582 |
| 510k Number | K171582 |
| Device Name: | NEO Pedicle Screw System™ |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Neo Medical S.A. Route De Lausanne 157A Villette (lavaux), CH 1096 |
| Contact | Jonas Larsson |
| Correspondent | Samuel Lainez confinis USA 2511 Saint Ignatius Court Orlando, FL 32835 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-31 |
| Decision Date | 2017-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B206RD0300ST0 | K171582 | 000 |
| B206RD0040PB0 | K171582 | 000 |
| B206RD0040SB0 | K171582 | 000 |
| B206RD0030SB0 | K171582 | 000 |
| B206SC7055PE0 | K171582 | 000 |
| B206SC7050PE0 | K171582 | 000 |
| B206SC7045PE0 | K171582 | 000 |
| B206SC7040PE0 | K171582 | 000 |
| B206SC7035PE0 | K171582 | 000 |
| B206SC6055PE0 | K171582 | 000 |
| B206SC6050PE0 | K171582 | 000 |
| B206SC6045PE0 | K171582 | 000 |
| B206SC6040PE0 | K171582 | 000 |
| B206SC6035PE0 | K171582 | 000 |
| B206SC5050PE0 | K171582 | 000 |
| 07640177820037 | K171582 | 000 |
| 07640177820020 | K171582 | 000 |
| B206RD0050PB0 | K171582 | 000 |
| B206RD0060PB0 | K171582 | 000 |
| B206RD0200ST0 | K171582 | 000 |
| B206RD0160ST0 | K171582 | 000 |
| B206RD0130ST0 | K171582 | 000 |
| B206RD0100ST0 | K171582 | 000 |
| B206RD0090ST0 | K171582 | 000 |
| B206RD0080ST0 | K171582 | 000 |
| B206RD0070ST0 | K171582 | 000 |
| B206RD0060ST0 | K171582 | 000 |
| B206RD0050ST0 | K171582 | 000 |
| B206RD0040ST0 | K171582 | 000 |
| B206RD0035ST0 | K171582 | 000 |
| B206RD0030ST0 | K171582 | 000 |
| B206RD0100PB0 | K171582 | 000 |
| B206RD0090PB0 | K171582 | 000 |
| B206RD0080PB0 | K171582 | 000 |
| B206RD0070PB0 | K171582 | 000 |
| 07640177820013 | K171582 | 000 |