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CheckMate®

FDA UDI

Class II (US FDA UDI)

by Arthrosurface Incorporated

Identity

Trade Name
CheckMate® FDA UDI
Generic Name
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile FDA UDI
Device Name
Screw, 3.0mm, Locking, 24mm FDA UDI
Model / Reference
4F01-1024 FDA UDI
Description
Screw, 3.0mm, Locking, 24mm FDA UDI

Identifiers

Catalog Number
4F01-1024 FDA UDI
Primary DI / UDI-DI
M5284F0110240 FDA UDI
510(k) Number
K113762 FDA UDI
FDA Product Code
HWC FDA UDI
GMDN Term
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 24 Millimeter FDA UDI

Category: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

CheckMate® by Arthrosurface Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile.

Cleared under the same submission

K113762 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Arthrosurface Incorporated

Sources (1)

  • FDA UDI b1afa447-2e0e-42e6-8190-557bd31cfa04 37 fields · synced May 30, 2026