| Primary Device ID | 07640177820679 |
| NIH Device Record Key | b6fc4342-9f56-4beb-8b7c-7076ff07d080 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Neo Medical Pedicle Screw System |
| Version Model Number | SI-PM-IN-NS |
| Company DUNS | 486778843 |
| Company Name | Neo Medical SA |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640177820679 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07640177820679]
Moist Heat or Steam Sterilization
[07640177820679]
Moist Heat or Steam Sterilization
[07640177820679]
Moist Heat or Steam Sterilization
[07640177820679]
Moist Heat or Steam Sterilization
[07640177820679]
Moist Heat or Steam Sterilization
[07640177820679]
Moist Heat or Steam Sterilization
[07640177820679]
Moist Heat or Steam Sterilization
[07640177820679]
Moist Heat or Steam Sterilization
[07640177820679]
Moist Heat or Steam Sterilization
[07640177820679]
Moist Heat or Steam Sterilization
[07640177820679]
Moist Heat or Steam Sterilization
[07640177820679]
Moist Heat or Steam Sterilization
[07640177820679]
Moist Heat or Steam Sterilization
[07640177820679]
Moist Heat or Steam Sterilization
[07640177820679]
Moist Heat or Steam Sterilization
[07640177820679]
Moist Heat or Steam Sterilization
[07640177820679]
Moist Heat or Steam Sterilization
[07640177820679]
Moist Heat or Steam Sterilization
[07640177820679]
Moist Heat or Steam Sterilization
[07640177820679]
Moist Heat or Steam Sterilization
[07640177820679]
Moist Heat or Steam Sterilization
[07640177820679]
Moist Heat or Steam Sterilization
[07640177820679]
Moist Heat or Steam Sterilization
[07640177820679]
Moist Heat or Steam Sterilization
[07640177820679]
Moist Heat or Steam Sterilization
[07640177820679]
Moist Heat or Steam Sterilization
[07640177820679]
Moist Heat or Steam Sterilization
[07640177820679]
Moist Heat or Steam Sterilization
[07640177820679]
Moist Heat or Steam Sterilization
[07640177820679]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-08 |
| Device Publish Date | 2020-08-31 |
| 07640177820679 | Pedicle marker inserter |
| 07640177821188 | Single Use Pedicle marker (2x) |
| 07640177821256 | Persuader (US Only) |
| 07640177821232 | Ratchet T-Handle - 1/4", NS |
| 07640177820884 | Screwdriver Converter - Hudson, NS |
| 07640177820877 | Screwdriver Converter - AO, NS |
| 07640177820860 | Screwdriver Handle, NS |
| 07640177820853 | Ratchet Screwdriver 1/4", NS |
| 07640177820815 | Ratchet Handle - 1/4", NS |
| 07640177820808 | Screwdriver Adaptor - 1/4", NS |
| 07640177820785 | Screwdriver Adaptor - Hudson, NS |
| 07640177820778 | Ratchet Handle - Hudson, NS |
| 07640177820433 | Screw driver Kit |
| 07640177820457 | 1.5mm K-wire (1x2) |
| 07640177821225 | Rod kit pre-bent 45 mm (2x) |
| 07640177821218 | Rod kit pre-bent 35 mm (2x) |
| 07640177821195 | Pedicle screw kit 2x(Ø5.0 x 30mm) |
| 07640177821072 | Revision Guide |
| 07640177821058 | Pedicle screw kit 2x(Ø8.0 x 40mm) |
| 07640177821041 | Pedicle screw kit 2x(Ø8.0 x 35mm) |
| 07640177821034 | Pedicle screw kit 2x(Ø7.0 x 30mm) |
| 07640177821027 | Pedicle screw kit 2x(Ø6.0 x 30mm) |
| 07640177820839 | Iliac connector - 70 mm |
| 07640177820822 | Iliac connector - 40 mm |
| 07640177821096 | Screw Guide Remover |