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HemiCAP®

FDA UDI

Class II (US FDA UDI)

by Arthrosurface Incorporated

Identity

Trade Name
HemiCAP® FDA UDI
Generic Name
Partial-resurfacing knee femur prosthesis FDA UDI
Device Name
Patello-Femoral, Fem Comp, 2.0x3.0 CE FDA UDI
Model / Reference
P202-2030-W FDA UDI
Description
Patello-Femoral, Fem Comp, 2.0x3.0 CE FDA UDI

Identifiers

Catalog Number
P202-2030-W FDA UDI
Primary DI / UDI-DI
M528P2022030W0 FDA UDI
510(k) Number
K060127 FDA UDI
FDA Product Code
KRR FDA UDI
GMDN Term
Partial-resurfacing knee femur prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 20 Millimeter FDA UDI

Category: Partial-resurfacing knee femur prosthesis

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

Similar devices

Also classified as Partial-resurfacing knee femur prosthesis.

Cleared under the same submission

K060127 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 a0953b57-4fc5-4b33-aea6-e078a6cbc51e 37 fields · synced Jun 8, 2026