Identity
- Trade Name
- SYNOVO HIP COMPONENTS FDA UDI
- Generic Name
- Bipolar humeral head outer component FDA UDI
- Device Name
- HIP SELF-ALIGNING ACETABULAR CUP & BEARING - 28 MM I.D. X 43 MM O.D. FDA UDI
- Model / Reference
- 01-17-2843 FDA UDI
- Description
- HIP SELF-ALIGNING ACETABULAR CUP & BEARING - 28 MM I.D. X 43 MM O.D. FDA UDI
Identifiers
- Catalog Number
- 01-17-2843 FDA UDI
- Primary DI / UDI-DI
- 00814193026019 FDA UDI
- 510(k) Number
- K884889 FDA UDI
- FDA Product Code
- KWL FDA UDI
- GMDN Term
- Bipolar humeral head outer component 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 43 Millimeter FDA UDILumen/Inner Diameter — 28 Millimeter FDA UDI
Category: Bipolar femoral head outer component, hemiarthroplastyBipolar humeral head outer component
Synovo Hip Components by Synovo Production — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bipolar humeral head outer component.
- B-P TOTAL HIP SYSTEM — ENDOTEC, INC. · Class II
- B-P TOTAL HIP SYSTEM — ENDOTEC, INC. · Class II
- B-P TOTAL HIP SYSTEM — ENDOTEC, INC. · Class II
- B-P TOTAL HIP SYSTEM — ENDOTEC, INC. · Class II
- B-P TOTAL HIP SYSTEM — ENDOTEC, INC. · Class II
- B-P TOTAL HIP SYSTEM — ENDOTEC, INC. · Class II
- B-P TOTAL HIP SYSTEM — ENDOTEC, INC. · Class II
- B-P TOTAL HIP SYSTEM — ENDOTEC, INC. · Class II
Cleared under the same submission
K884889 also covers:
- B-P TOTAL HIP SYSTEM — ENDOTEC, INC.
- B-P TOTAL HIP SYSTEM — ENDOTEC, INC.
- B-P TOTAL HIP SYSTEM — ENDOTEC, INC.
- B-P TOTAL HIP SYSTEM — ENDOTEC, INC.
- B-P TOTAL HIP SYSTEM — ENDOTEC, INC.
- B-P TOTAL HIP SYSTEM — ENDOTEC, INC.
- B-P TOTAL HIP SYSTEM — ENDOTEC, INC.
- B-P TOTAL HIP SYSTEM — ENDOTEC, INC.
- B-P TOTAL HIP SYSTEM — ENDOTEC, INC.
- B-P TOTAL HIP SYSTEM — ENDOTEC, INC.
- B-P TOTAL HIP SYSTEM — ENDOTEC, INC.
- B-P TOTAL HIP 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 |
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Manufacturer
- Manufacturer
- Synovo Production
Sources (1)
- FDA UDI 460cad11-19c5-444b-a6d2-c616ad6cb83c 37 fields · synced May 30, 2026