Coral

FDA UDI

Class II (US FDA UDI)

by SeaSpine Orthopedics Corporation

Identity

Trade Name: Coral FDA UDI
Generic Name: Spinal bone set screw FDA UDI
Device Name: Locking Screw Assembly. 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: 10-17-0001 FDA UDI
Description: Locking Screw Assembly. 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: 10-17-0001 FDA UDI
Primary DI / UDI-DI: 10889981027520 FDA UDI
510(k) Number: K041592 FDA UDI
FDA Product Code: MNH FDA UDI
MNI FDA UDI
KWQ FDA UDI
KWP FDA UDI
NKB FDA UDI
GMDN Term: Spinal bone set screw FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3070 FDA UDI
888.3060 FDA UDI
888.3050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Spinal bone set screw

Coral by SeaSpine Orthopedics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

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 714a8f34-c221-43b1-974b-354a0feaec64 36 fields · synced Jun 8, 2026