CosmoLock Pedicle Screw System
- Primary DI
- B07311K0100260
- Brand
- CosmoLock Pedicle Screw System
- Company
- Kalitec Direct LLC
- Model
- 11-K01-0026
- Device description
- Tray Insert, Lumbar Screw Rack 10 x 10
- Published
- 2018-09-18
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| FSM | Tray, Surgical, Instrument |
| LRP | Tray, Surgical |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | 1 |
| LRP | Tray, Surgical | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| B07311K0100260 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Surgical instrument/implant rack | A device designed as a small case, typically with a hinged lid that can be closed to protect the contents (i.e., surgical instruments and/or implantable devices such as plates or screws), and an integral rest(s) with grooves or notches in the upper edge so that the contents can be securely placed, protected, and organized. The lid or rest may be set at an angle to facilitate instrument/implant access during surgical procedures or sterilization. The device is typically be made of stainless steel or a suitable plastic material so that it can be sterilized. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 041956211
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| B07315K0112220 | NIDO Pedicle Screw System | 15-K01-1222 | 15-K01-1222 | 2025-03-19 |
| B07315K0112300 | NIDO Pedicle Screw System | 15-K01-1230 | 15-K01-1230 | 2025-03-19 |
| B07315CLA50100 | NIDO Pedicle Screw System | 15-CLA-5010 | 15-CLA-5010 | 2024-09-19 |
| B07315CLA51100 | NIDO Pedicle Screw System | 15-CLA-5110 | 15-CLA-5110 | 2024-09-19 |
| B07330TNS27070 | Navagio Lumbar Cage | 30-TNS-2707 | 30-TNS-2707 | 2024-08-12 |
| B07330TTS27070 | Navagio Lumbar Cage | 30-TTS-2707 | 30-TTS-2707 | 2024-08-12 |
| B07311K0130400 | Cosmolock | 11-K01-3040 | 11-K01-3040 | 2024-06-20 |
| B07315K0120120 | NIDO Pedicle Screw System | 15-K01-2012 | 15-K01-2012 | 2024-05-31 |
| B07315K0120100 | NIDO Pedicle Screw System | 15-K01-2010 | 15-K01-2010 | 2024-05-02 |
| B07315K0170000 | NIDO Pedicle Screw System | 15-K01-7000 | 15-K01-7000 | 2024-03-01 |
| B07310BRS02300 | Cosmolock | 10-BRS-0230 | 10-BRS-0230 | 2024-01-16 |
| B07315BCC05000 | NIDO Pedicle Screw System | 15-BCC-0500 | 15-BCC-0500 | 2023-10-06 |
| B07315BCC05050 | NIDO Pedicle Screw System | 15-BCC-0505 | 15-BCC-0505 | 2023-10-06 |
| B07315BCC05100 | NIDO Pedicle Screw System | 15-BCC-0510 | 15-BCC-0510 | 2023-10-06 |
| B07315BCC05150 | NIDO Pedicle Screw System | 15-BCC-0515 | 15-BCC-0515 | 2023-10-06 |
| B07315BCC05250 | NIDO Pedicle Screw System | 15-BCC-0525 | 15-BCC-0525 | 2023-10-06 |
| B07315BCC05300 | NIDO Pedicle Screw System | 15-BCC-0530 | 15-BCC-0530 | 2023-10-06 |
| B07315BCC05350 | NIDO Pedicle Screw System | 15-BCC-0535 | 15-BCC-0535 | 2023-10-06 |
| B07315BCC05400 | NIDO Pedicle Screw System | 15-BCC-0540 | 15-BCC-0540 | 2023-10-06 |
| B07315BCC05450 | NIDO Pedicle Screw System | 15-BCC-0545 | 15-BCC-0545 | 2023-10-06 |
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