Identity
- Trade Name
- B-P TOTAL SHOULDER SYSTEM FDA UDI
- Generic Name
- Total shoulder prosthesis FDA UDI
- Device Name
- B-P SHOULDER HUMERAL STEM W/O HEAD W/ BIOCOAT & W/ULTRACOAT - 14 MM FDA UDI
- Model / Reference
- 02-04-0114 FDA UDI
- Description
- B-P SHOULDER HUMERAL STEM W/O HEAD W/ BIOCOAT & W/ULTRACOAT - 14 MM FDA UDI
Identifiers
- Catalog Number
- 02-04-0114 FDA UDI
- Primary DI / UDI-DI
- 00814193025364 FDA UDI
- 510(k) Number
- K904880 FDA UDI
- FDA Product Code
- KWS FDA UDI
- GMDN Term
- Total shoulder prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 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 — 14 Millimeter FDA UDI
Category: Total shoulder prosthesis
B-P Total Shoulder System by Endotec, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Total shoulder prosthesis.
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- Shoulder Innovations Humeral Stemless System — SHOULDER INNOVATIONS, Inc · Class II
- Shoulder Innovations Inset Reverse Total Shoulder — SHOULDER INNOVATIONS, Inc · Class II
- Shoulder System — Medacta International · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- Arthrex® — Arthrex, Inc. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
Cleared under the same submission
K904880 also covers:
- B-P TOTAL SHOULDER SYSTEM — ENDOTEC, INC.
- B-P TOTAL SHOULDER SYSTEM — ENDOTEC, INC.
- B-P TOTAL SHOULDER SYSTEM — ENDOTEC, INC.
- B-P TOTAL SHOULDER SYSTEM — ENDOTEC, INC.
- B-P TOTAL SHOULDER SYSTEM — ENDOTEC, INC.
- B-P TOTAL SHOULDER SYSTEM — ENDOTEC, INC.
- B-P TOTAL SHOULDER SYSTEM — ENDOTEC, INC.
- B-P TOTAL SHOULDER SYSTEM — ENDOTEC, INC.
- B-P TOTAL SHOULDER SYSTEM — ENDOTEC, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Endotec, Inc.
Sources (1)
- FDA UDI e13ed181-49fb-43dd-89c6-16ecf7f673c9 37 fields · synced May 30, 2026