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Coral

FDA UDI

Class II (US FDA UDI)

by SeaSpine Orthopedics Corporation

Identity

Trade Name
Coral FDA UDI
Generic Name
Bone-screw internal spinal fixation system, non-sterile FDA UDI
Device Name
Solid Polyaxial Screw, 6.50mm x 25mm FDA UDI
Model / Reference
18-12-6525 FDA UDI
Description
Solid Polyaxial Screw, 6.50mm x 25mm FDA UDI

Identifiers

Catalog Number
18-12-6525 FDA UDI
Primary DI / UDI-DI
10889981015961 FDA UDI
510(k) Number
K070962 FDA UDI
FDA Product Code
KWQ FDA UDI
KWP FDA UDI
NKB FDA UDI
MNH FDA UDI
MNI FDA UDI
GMDN Term
Bone-screw internal spinal fixation system, non-sterile FDA UDI

Classification

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

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Bone-screw internal spinal fixation system, non-sterile

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

Similar devices

Also classified as Bone-screw internal spinal fixation system, non-sterile.

Cleared under the same submission

K070962 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
SeaSpine Orthopedics Corporation

Sources (1)

  • FDA UDI 4c9dfd8b-bcee-4a19-b599-cac7d1a7e084 37 fields · synced Jun 8, 2026