Zyston Interbody Spacer System
- Primary DI
- 03662663155236
- Company
- Highridge Medical, LLC
- Model
- 14-533130
- Catalog number
- 14-533130
- Device description
- Curve Spacer 10H x 27L 6° PEEK Lordotic
- Published
- 2026-02-16
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
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
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 03662663155236 | Primary | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 03662663155236 | 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 |
|---|
| Polymeric spinal interbody fusion cage | A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device. |
Device Sizes
No records found.
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | keep out of sunlight |
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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