HemiCAP®

FDA UDI

Class II (US FDA UDI)

by Arthrosurface Incorporated

Identity

Trade Name: HemiCAP® FDA UDI
Generic Name: Shoulder prosthesis screw FDA UDI
Device Name: 10.0mm x 31mm, Taper Post, Humeral Head FDA UDI
Model / Reference: 8135-1875-A FDA UDI
Description: 10.0mm x 31mm, Taper Post, Humeral Head FDA UDI

Identifiers

Catalog Number: 8135-1875-A FDA UDI
Primary DI / UDI-DI: M52881351875A0 FDA UDI
510(k) Number: K023096 FDA UDI
FDA Product Code: HSD FDA UDI
GMDN Term: Shoulder prosthesis screw FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3690 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 10.0 Millimeter FDA UDI

Category: Shoulder prosthesis screw

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

Similar devices

Also classified as Shoulder prosthesis screw.

Comprehensive Reverse Shoulder — Biomet Orthopedics, Inc. · Class II
COMPREHENSIVE SRS — Biomet Orthopedics, Inc. · Class II
COMPREHENSIVE REVERSE SHOULDER — Biomet Orthopedics, Inc. · Class II
Equinoxe — Exactech, Inc. · Class II
Equinoxe — Exactech, Inc. · Class II
Humelock II Cementless Shoulder System — FX SOLUTIONS · Class II
Titan™ — Ascension Orthopedics, Inc. · Class II
Titan™ — Ascension Orthopedics, Inc. · Class II

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: Arthrosurface Incorporated

Sources (1)

FDA UDI 860195b9-fb37-47d5-97a9-d524e25a3184 37 fields · synced Jun 8, 2026