Identity
- Trade Name
- ENDO SH 41 FDA UDI
- Generic Name
- Bipolar femoral head outer component, hemiarthroplasty FDA UDI
- Model / Reference
- 10189 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M209101890 FDA UDI
- 510(k) Number
- K895886 FDA UDI
- FDA Product Code
- KWL FDA UDI
- GMDN Term
- Bipolar femoral head outer component, hemiarthroplasty FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3360 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Bipolar femoral head outer component, hemiarthroplasty
Endo Sh 41 by Biopro, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bipolar femoral head outer component, hemiarthroplasty.
- Pivot Bipolar — ORTHO DEVELOPMENT CORP. · Class II
- BIO-MOORE ENDO II HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
- TANDEM — Smith & Nephew, Inc. · Class II
- Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- Endohead — Medacta International · Class II
- UHR — Howmedica Osteonics Corp. · Class II
- SLR BIPOLAR — MicroPort Orthopedics Inc. · Class II
- MultiPolar® — Zimmer, Inc. · Class II
Cleared under the same submission
K895886 also covers:
- ENDO MD 38 — BIOPRO, INC.
- ENDO MD 41 — BIOPRO, INC.
- ENDO MD 43 — BIOPRO, INC.
- ENDO MD 45 — BIOPRO, INC.
- ENDO MD 47 — BIOPRO, INC.
- ENDO MD 49 — BIOPRO, INC.
- ENDO MD 51 — BIOPRO, INC.
- ENDO MD 53 — BIOPRO, INC.
- ENDO MD 55 — BIOPRO, INC.
- ENDO SH 38 — BIOPRO, INC.
- ENDO SH 43 — BIOPRO, INC.
- ENDO SH 45 — BIOPRO, INC.
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
- Biopro, Inc.
Sources (1)
- FDA UDI a439ec40-0f46-436c-bbcc-e30491b80d51 33 fields · synced May 30, 2026