Identity
- Trade Name
- HemiCAP® FDA UDI
- Generic Name
- Shoulder humeral body prosthesis FDA UDI
- Device Name
- Art. Comp., 40mm, .1875 Post, 11.0mm x 11.0mm CE FDA UDI
- Model / Reference
- 8402-1111-W FDA UDI
- Description
- Art. Comp., 40mm, .1875 Post, 11.0mm x 11.0mm CE FDA UDI
Identifiers
- Catalog Number
- 8402-1111-W FDA UDI
- Primary DI / UDI-DI
- M52884021111W0 FDA UDI
- 510(k) Number
- K023096 FDA UDI
- FDA Product Code
- HSD FDA UDI
- GMDN Term
- Shoulder humeral body prosthesis 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
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Outer Diameter — 40 Millimeter FDA UDI
Category: Shoulder humeral body prosthesis
The HemiCAP device is a modular shoulder replacement system designed for patients requiring hip or shoulder replacements. It features a sterile implantable component made of metal (Co-Cr-Mo) or titanium, used in a comprehensive total shoulder prosthesis system. The device is intended to provide long-lasting and reliable functionality.
Similar devices
Also classified as Shoulder humeral body prosthesis.
- Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG · Class II
- Equinoxe — Exactech, Inc. · Class II
- Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG · Class II
- Anatomical Shoulder™ Domelock® — Zimmer, Inc. · Class II
- Humeris Shoulder — FX SOLUTIONS · Class II
- Equinoxe — Exactech, Inc. · Class II
- GLOBAL UNITE — DEPUY (IRELAND) · Class II
- Equinoxe — Exactech, Inc. · Class II
Cleared under the same submission
K023096 also covers:
- HemiCAP® — ARTHROSURFACE INCORPORATED
- HemiCAP® — ARTHROSURFACE INCORPORATED
- HemiCAP® — ARTHROSURFACE INCORPORATED
- HemiCAP® — ARTHROSURFACE INCORPORATED
- HemiCAP® — ARTHROSURFACE INCORPORATED
- HemiCAP® — ARTHROSURFACE INCORPORATED
- HemiCAP® — ARTHROSURFACE INCORPORATED
- HemiCAP® — ARTHROSURFACE INCORPORATED
- HemiCAP® — ARTHROSURFACE INCORPORATED
- HemiCAP® — ARTHROSURFACE INCORPORATED
- HemiCAP® — ARTHROSURFACE INCORPORATED
- HemiCAP® — ARTHROSURFACE INCORPORATED
Authorization Coverage (1 country)
Regulatory Authorizations
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 6a2bad6e-cb57-489e-a87a-f6882e034ab6 37 fields · synced Jun 24, 2026