Identity
- Trade Name
- ECHO FX HIP SYSTEM FDA UDI
- Generic Name
- Uncoated femoral stem prosthesis, one-piece FDA UDI
- Model / Reference
- 12-151415 FDA UDI
Identifiers
- Catalog Number
- 12-151415 FDA UDI
- Primary DI / UDI-DI
- 00880304520301 FDA UDI
- 510(k) Number
- K063614 FDA UDI
- FDA Product Code
- MAY FDA UDILWJ FDA UDIKWL FDA UDIKWZ FDA UDILPH FDA UDIKWY FDA UDIMEH FDA UDILZO FDA UDIJDI FDA UDI
- GMDN Term
- Uncoated femoral stem prosthesis, one-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3360 FDA UDI888.3310 FDA UDI888.3358 FDA UDI888.3390 FDA UDI888.3350 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
Category: Uncoated femoral stem prosthesis, one-piece
Echo Fx Hip System by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated femoral stem prosthesis, one-piece.
- Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class III
- Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class III
- Alteon — Exactech, Inc. · Class II
- OrthoMedFlex — ORTHOMEDFLEX LLC · Class II
- Novation — Exactech, Inc. · Class II
- Evolve Masters — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
- Acumatch C Series — Exactech, Inc. · Class II
Cleared under the same submission
K063614 also covers:
- ECHO FX HIP SYSTEM — Biomet Orthopedics, Inc.
- ECHO FX HIP SYSTEM — Biomet Orthopedics, Inc.
- ECHO FX HIP SYSTEM — Biomet Orthopedics, Inc.
- ECHO FX HIP SYSTEM — Biomet Orthopedics, Inc.
- ECHO FX HIP SYSTEM — Biomet Orthopedics, Inc.
- ECHO FX HIP SYSTEM — Biomet Orthopedics, Inc.
- ECHO FX HIP SYSTEM — Biomet Orthopedics, Inc.
- ECHO FX HIP SYSTEM — Biomet Orthopedics, Inc.
- ECHO FX HIP SYSTEM — Biomet Orthopedics, Inc.
- ECHO FX HIP SYSTEM — Biomet Orthopedics, Inc.
- Echo FX™ Hip System — Biomet Orthopedics, Inc.
- Echo FX™ Hip System — Biomet Orthopedics, 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
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI be521db3-a579-47fa-8381-a7212a93eef7 36 fields · synced Jun 1, 2026