Mariner Deformity MD3-203004
by SeaSpine Orthopedics Corporation
Listed
Valid until
Not applicable
FDA recalls
2 ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10889981302085 | Date19 Dec 2025 | StatusListed |
Recalls
-
- Ongoing Z-1620-2024
Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
-
- Ongoing Z-1605-2024
Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Mariner Deformity
- Generic Name
- Instrument tray, reusable
- Model / Ref / Catalog
- MD3-203004
- Primary DI / UDI-DI
- 10889981302085
- 510(k) Number
- FDA Product Code
- NKB, KWQ, KWP
- GMDN Term
- Instrument tray, reusable
- Device Class
- Class II
- Regulation Number
- 888.3070, 888.3060, 888.3050
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Other devices from SeaSpine Orthopedics Corporation
Properties
Other properties (12)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No