Fuse Pedicle Screw System
- Primary DI
- B565FZI0320
- Brand
- Fuse Pedicle Screw System
- Company
- CPM MEDICAL CONSULTANTS, LLC
- Model
- FZ-I-032
- Device description
- Compressor Distractor
- Published
- 2023-08-25
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- true
- Single use
- false
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 |
|---|
| B565FZI0320 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Orthopaedic surgical procedure kit, non-medicated, reusable | A collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 017138000
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- 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
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|---|
| B565M32205016L1 | STERIZO Total Knee System | M-3220-5016L | M-3220-5016L | 2026-02-26 |
| B565M32205016S1 | STERIZO Total Knee System | M-3220-5016S | M-3220-5016S | 2026-02-26 |
| B56510516001 | Fuse ULTRA FOOT PLATING SYSTEM | 105-16-00 | 105-16-00 | 2025-09-18 |
| B565OS0000011 | Fuse ULTRA FOOT PLATING SYSTEM | OS000001 | OS000001 | 2025-08-01 |
| B565OS0230201 | Fuse ULTRA FOOT PLATING SYSTEM | OS023020 | OS023020 | 2025-08-01 |
| B565OS4225081 | Fuse ULTRA FOOT PLATING SYSTEM | OS422508 | OS422508 | 2025-08-01 |
| B565OS4225101 | Fuse ULTRA FOOT PLATING SYSTEM | OS422510 | OS422510 | 2025-08-01 |
| B565OS4225121 | Fuse ULTRA FOOT PLATING SYSTEM | OS422512 | OS422512 | 2025-08-01 |
| B565OS4225141 | Fuse ULTRA FOOT PLATING SYSTEM | OS422514 | OS422514 | 2025-08-01 |
| B565OS4225161 | Fuse ULTRA FOOT PLATING SYSTEM | OS422516 | OS422516 | 2025-08-01 |
| B565OS4225181 | Fuse ULTRA FOOT PLATING SYSTEM | OS422518 | OS422518 | 2025-08-01 |
| B565OS4225201 | Fuse ULTRA FOOT PLATING SYSTEM | OS422520 | OS422520 | 2025-08-01 |
| B565OS4225221 | Fuse ULTRA FOOT PLATING SYSTEM | OS422522 | OS422522 | 2025-08-01 |
| B565OS4225241 | Fuse ULTRA FOOT PLATING SYSTEM | OS422524 | OS422524 | 2025-08-01 |
| B565OS4225261 | Fuse ULTRA FOOT PLATING SYSTEM | OS422526 | OS422526 | 2025-08-01 |
| B565OS4225281 | Fuse ULTRA FOOT PLATING SYSTEM | OS422528 | OS422528 | 2025-08-01 |
| B565OS4225301 | Fuse ULTRA FOOT PLATING SYSTEM | OS422530 | OS422530 | 2025-08-01 |
| B565OS4226081 | Fuse ULTRA FOOT PLATING SYSTEM | OS422608 | OS422608 | 2025-08-01 |
| B565OS4226101 | Fuse ULTRA FOOT PLATING SYSTEM | OS422610 | OS422610 | 2025-08-01 |
| B565OS4226121 | Fuse ULTRA FOOT PLATING SYSTEM | OS422612 | OS422612 | 2025-08-01 |
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