Cosmolock Pedicle Screw System
- Primary DI
- B07310SCT75301
- Brand
- Cosmolock Pedicle Screw System
- Company
- Kalitec Direct LLC
- Model
- 10-SCT-7530
- Catalog number
- 10-SCT-7530
- Device description
- SCREW, CANN TTAB, 7.5MM X 30MM
- Published
- 2017-12-15
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| NKB | Thoracolumbosacral Pedicle Screw System |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| B07310SCT75301 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Bone-screw internal spinal fixation system, non-sterile | An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included. |
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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