Identity
- Trade Name
- OrthoMedFlex FDA UDI
- Generic Name
- Ceramic femoral head prosthesis FDA UDI
- Device Name
- Ceramic Femoral Head, 28mm, XXL (+10 mm) FDA UDI
- Model / Reference
- 111152615 FDA UDI
- Description
- Ceramic Femoral Head, 28mm, XXL (+10 mm) FDA UDI
Identifiers
- Catalog Number
- 111-152-615 FDA UDI
- Primary DI / UDI-DI
- M7161111526150 FDA UDI
- FDA Product Code
- LPH FDA UDI
- GMDN Term
- Ceramic femoral head prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ceramic femoral head prosthesis
Discover the latest innovation in orthopedic technology with the OrthoMedFlex ceramic femoral head prosthetic, designed to revolutionize total hip arthroplasty and partial hip replacement procedures. Made from advanced ceramic materials, this implantable device provides superior stability and performance compared to traditional implants.
Similar devices
Also classified as Ceramic femoral head prosthesis.
- Ceramic ball head — Beijing LiDaKang Technology Co., Ltd. · Class III
- ELEC(R)plus — HiPer Medical AG · Class III
- BIOLOX® delta Modular Ceramic Head — Biomet Uk Ltd · Class II
- InSitu Hip System — Nextstep Arthropedix · Class II
- Prosthesis Head A — WALDEMAR LINK GmbH & Co. KG · Class II
- InSitu Hip System — Nextstep Arthropedix · Class II
- SYNERGY — Smith & Nephew, Inc. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
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
- Orthomedflex Llc
Sources (1)
- FDA UDI 050fd65e-2b13-4dd7-8526-c5c01d516606 34 fields · synced Jul 29, 2026