Zyston Interbody Spacer System
- Primary DI
- 03662663131087
- Company
- Highridge Medical, LLC
- Model
- 137M0019
- Catalog number
- 137M0019
- Device description
- Outer Shaft, C-Clamp
- 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 |
|---|
| 03662663131087 | Primary | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 03662663131087 | 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 |
|---|
| Medical device service rail clamp | A clamp designed to fit onto a medical device mounting rail or medical device service rail system to provide a secure method of fixing/mounting (holding) other medical or non-medical devices being used in the vicinity for patient treatment/care. It will typically be used in a hospital ward, a treatment room or an intensive care unit (ICU). It will have a gripping profile that is compatible to the medical rail it is intended to fit and a locking mechanism providing extra safety against inadvertent loosening. To this clamp, other adaptors may be fitted/slotted to provide holders for the devices to be carried, or it may have a dedicated function for which it is solely designed. |
Device Sizes
| Type | Value | Text |
|---|
| Device Size Text, specify | 0 | Outer Shaft, C-Clamp |
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 |
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| 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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