Identity
- Trade Name
- Modal Total Hip System FDA UDI
- Generic Name
- Metal-on-polyethylene total hip prosthesis FDA UDI
- Device Name
- Femoral Head, CoCr Sz 32 S FDA UDI
- Model / Reference
- M-1300-3201 FDA UDI
- Description
- Femoral Head, CoCr Sz 32 S FDA UDI
Identifiers
- Primary DI / UDI-DI
- B035M130032011 FDA UDI
- 510(k) Number
- K143314 FDA UDI
- FDA Product Code
- LZO FDA UDILPH FDA UDI
- GMDN Term
- Metal-on-polyethylene total hip prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3358 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
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: Metal-on-polyethylene total hip prosthesis
Modal Total Hip System by Modal Manufacturing Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metal-on-polyethylene total hip prosthesis.
- U2 Femoral head, Ø36mm, +0mm — UNITED ORTHOPEDIC CORP. · Class II
- Libertas — MAXX ORTHOPEDICS INC. · Class II
- Libertas — MAXX ORTHOPEDICS INC. · Class II
- Cancellous Bone Screw with 6.5mm Head Diameter, 30mm — TOTAL JOINT ORTHOPEDICS, INC. · Class II
- "UNITED" USTAR II Hip System — UNITED ORTHOPEDIC CORP. · Class II
- Conformis Hip System — Conformis, Inc. · Class II
- Encompass Hip Stem — ORTHO DEVELOPMENT CORP. · Class II
- Initia Total Hip System — Kyocera Corporation · Class II
Cleared under the same submission
K143314 also covers:
- STERIZO Total Hip System — CPM Medical Consultants, LLC
- STERIZO Total Hip System — CPM Medical Consultants, LLC
- STERIZO Total Hip System — CPM Medical Consultants, LLC
- STERIZO Total Hip System — CPM Medical Consultants, LLC
- STERIZO Total Hip System — CPM Medical Consultants, LLC
- STERIZO Total Hip System — CPM Medical Consultants, LLC
- STERIZO Total Hip System — CPM Medical Consultants, LLC
- STERIZO Total Hip System — CPM Medical Consultants, LLC
- STERIZO Total Hip System — CPM Medical Consultants, LLC
- STERIZO Total Hip System — CPM Medical Consultants, LLC
- STERIZO Total Hip System — CPM Medical Consultants, LLC
- STERIZO Total Hip System — CPM Medical Consultants, LLC
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
- Modal Manufacturing Llc
Sources (1)
- FDA UDI 667006dd-3c99-4e74-a9c0-5df282fbd4d4 34 fields · synced May 31, 2026