Identity
- Trade Name
- Coral FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system hook FDA UDI
- Device Name
- Extended Lamina Hook-Lg. The Coral Spinal System consists of a variety of types and sizes of rods, hooks, screws, and connectors. The Coral Spinal System implant components can be rigidly locked into a variety of configurations that can be fit for the individual case. The Coral Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136, ASTM-F-67, and cobalt chrome alloy per ASTM F-1537. FDA UDI
- Model / Reference
- 10-21-1009 FDA UDI
- Description
- Extended Lamina Hook-Lg. The Coral Spinal System consists of a variety of types and sizes of rods, hooks, screws, and connectors. The Coral Spinal System implant components can be rigidly locked into a variety of configurations that can be fit for the individual case. The Coral Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136, ASTM-F-67, and cobalt chrome alloy per ASTM F-1537. FDA UDI
Identifiers
- Catalog Number
- 10-21-1009 FDA UDI
- Primary DI / UDI-DI
- 10889981027742 FDA UDI
- 510(k) Number
- K041592 FDA UDI
- FDA Product Code
- MNH FDA UDIKWQ FDA UDIMNI FDA UDINKB FDA UDIKWP FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system hook FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3060 FDA UDI888.3050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone-screw internal spinal fixation system hook
Coral by SeaSpine Orthopedics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone-screw internal spinal fixation system hook.
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Cleared under the same submission
K041592 also covers:
- Coral — SeaSpine Orthopedics Corporation
- Coral — SeaSpine Orthopedics Corporation
- Coral — SeaSpine Orthopedics Corporation
- Coral — SeaSpine Orthopedics Corporation
- Coral — SeaSpine Orthopedics Corporation
- Coral — SeaSpine Orthopedics Corporation
- Coral — SeaSpine Orthopedics Corporation
- Coral — SeaSpine Orthopedics Corporation
- Coral — SeaSpine Orthopedics Corporation
- Coral — SeaSpine Orthopedics Corporation
- Coral — SeaSpine Orthopedics Corporation
- Coral — SeaSpine Orthopedics Corporation
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- SeaSpine Orthopedics Corporation
Sources (1)
- FDA UDI 88c2315a-f508-40d8-9967-0128380265c2 36 fields · synced Jun 8, 2026