Zyston Interbody Spacer System
- Primary DI
- 03662663130813
- Company
- Highridge Medical, LLC
- Model
- 136M2806
- Catalog number
- 136M2806
- Device description
- Curved Trial 28L x 06H x 10W mm
- Published
- 2026-03-11
- 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
Regulatory Flags
- DUNS number
- 119260394
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- 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
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 03662663130813 | Primary | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 03662663130813 | Primary | GS1 | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Orthopedic | 888.3080 | Y | Eligible |
Premarket Submissions
No records found.
Premarket Details
No records found.
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. |
Device Sizes
| Type | Value | Text |
|---|
| Device Size Text, specify | 0 | Curved Trial 28L x 06H x 10W mm Parallel |
Storage And Handling
No records found.
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts
| Phone | Email |
|---|
| +1(800)447-3625 | usbrocustomerservice@highridgemedical.com |
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 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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