Timberline Lateral Fusion System
- Primary DI
- 03662663265485
- Brand
- Timberline Lateral Fusion System
- Company
- Highridge Medical, LLC
- Model
- 8732-2316
- Catalog number
- 8732-2316
- Device description
- TRIAL CT IMPLANT LATERAL 0DEG 22 X 16
- Published
- 2025-11-16
- Public version status
- New
- 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 |
|---|
| MAX | Intervertebral fusion device with bone graft, lumbar |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 03662663265485 | Primary | GS1 | 0 | |
Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.
Alternate GTIN / UPC / EAN Codes
| Source identifier | Source length | GTIN-14 normalized | Indicator | EAN-13 | Conversion note |
|---|
| 03662663265485 | 14 | 03662663265485 | 0 | 3662663265485 | Indicator 0 allows EAN-13 conversion; UPC-A requires prefix 00. |
GMDN Terms
| Term | Definition |
|---|
| Spinal implant trial | A copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 119260394
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- 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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|---|
| 03662663130929 | Zyston Interbody Spacer System | 136M3306 | 136M3306 | 2026-03-17 |
| 03662663130936 | Zyston Interbody Spacer System | 136M3307 | 136M3307 | 2026-03-17 |
| 03662663131117 | Zyston Interbody Spacer System | 139M2606 | 139M2606 | 2026-03-17 |
| 03662663136693 | Polaris 5.5 Spinal Fixation System | 14-501810 | 14-501810 | 2026-03-17 |
| 03662663136709 | Polaris 5.5 Spinal Fixation System | 14-501811 | 14-501811 | 2026-03-17 |
| 03662663136723 | Polaris 5.5 Spinal Fixation System | 14-501813 | 14-501813 | 2026-03-17 |
| 03662663143462 | MaxAn Anterior Cervical Plate System | 14-522038 | 14-522038 | 2026-03-17 |
| 03662663143479 | MaxAn Anterior Cervical Plate System | 14-522039 | 14-522039 | 2026-03-17 |
| 03662663143486 | MaxAn Anterior Cervical Plate System | 14-522040 | 14-522040 | 2026-03-17 |
| 03662663143493 | MaxAn Anterior Cervical Plate System | 14-522041 | 14-522041 | 2026-03-17 |
| 03662663143509 | MaxAn Anterior Cervical Plate System | 14-522042 | 14-522042 | 2026-03-17 |
| 03662663143516 | MaxAn Anterior Cervical Plate System | 14-522043 | 14-522043 | 2026-03-17 |
| 03662663143523 | MaxAn Anterior Cervical Plate System | 14-522044 | 14-522044 | 2026-03-17 |
| 03662663143530 | MaxAn Anterior Cervical Plate System | 14-522045 | 14-522045 | 2026-03-17 |
| 03662663085458 | FlareHawk | ASY-00003 | ASY-00003 | 2025-10-03 |
| 03662663085502 | FlareHawk | ASY-00018 | ASY-00018 | 2025-10-03 |
| 03662663085533 | FlareHawk | ASY-00040 | ASY-00040 | 2025-10-03 |
| 03662663085540 | FlareHawk | ASY-00041 | ASY-00041 | 2025-10-03 |
| 03662663085632 | FlareHawk | ASY-00064 | ASY-00064 | 2025-10-03 |
| 03662663085663 | FlareHawk | ASY-00067 | ASY-00067 | 2025-10-03 |
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