Identity
- Trade Name
- Modal Total Hip System FDA UDI
- Generic Name
- Metal-on-polyethylene total hip prosthesis FDA UDI
- Device Name
- Bone Screw, 6.5mm X 30mm FDA UDI
- Model / Reference
- M-EBS-6530 FDA UDI
- Description
- Bone Screw, 6.5mm X 30mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- B035MEBS65301 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 prosthesisCeramic-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 Ceramic-on-polyethylene total hip prosthesis.
- STERIZO Total Hip System — CPM Medical Consultants, LLC · Class II
- Ceramic Femoral Head BIOLOX® Delta 12/14S — UNITED ORTHOPEDIC CORP. · Class II
- Conformis Hip System — Conformis, Inc. · Class II
- United Hip System, U-Motion II PS Cup, Multi-Hole — UNITED ORTHOPEDIC CORP. · Class II
- United Hip System, U-Motion II XPE Cup Liner — UNITED ORTHOPEDIC CORP. · Class II
- B-P TOTAL HIP SYSTEM — ENDOTEC, INC. · Class II
- STERIZO Total Hip System — CPM Medical Consultants, LLC · Class II
- STERIZO Total Hip System — CPM Medical Consultants, LLC · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Modal Manufacturing Llc
Sources (1)
- FDA UDI 25476a46-fbbb-48cc-8e0f-269e31776054 34 fields · synced Jun 8, 2026