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CoreLink LATERAL PLATE - 2 SCREW

FDA UDI

Class II (US FDA UDI)

by Corelink Llc

Identity

Trade Name
CoreLink LATERAL PLATE - 2 SCREW FDA UDI
Generic Name
Spinal fixation plate, non-bioabsorbable FDA UDI
Device Name
LATERAL PLATE - 2 SCREW, 15MM X 18MM FDA UDI
Model / Reference
900215-18 FDA UDI
Description
LATERAL PLATE - 2 SCREW, 15MM X 18MM FDA UDI

Identifiers

Primary DI / UDI-DI
M72590021518 FDA UDI
510(k) Number
K190016 FDA UDI
FDA Product Code
KWQ FDA UDI
GMDN Term
Spinal fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3060 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

CoreLink LATERAL PLATE - 2 SCREW by Corelink Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K190016 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Corelink Llc

Sources (1)

  • FDA UDI 4a9d6fbe-37ae-4e8a-9a92-75932334f18d 36 fields · synced May 31, 2026