Identity
- Trade Name
- Modal Total Hip System FDA UDI
- Generic Name
- Acetabulum prosthesis trial, prefabricated, reusable FDA UDI
- Device Name
- Trial Shell, Cluster Hole Sz 62 FDA UDI
- Model / Reference
- M-1400-0062 FDA UDI
- Description
- Trial Shell, Cluster Hole Sz 62 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B035M140000621 FDA UDI
- 510(k) Number
- K143314 FDA UDI
- FDA Product Code
- LZO FDA UDILPH FDA UDI
- GMDN Term
- Acetabulum prosthesis trial, prefabricated, reusable 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Acetabulum prosthesis trial, prefabricated, reusable
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 Acetabulum prosthesis trial, prefabricated, reusable.
- Trabecular Metal® — Zimmer, Inc. · Class I
- G7 PROVISIONAL SHELL — Biomet Orthopedics, Inc. · Class II
- Bipolar Head — Limacorporate · Class II
- Acetabular Cups — Limacorporate · Class II
- Novation — Exactech, Inc. · Class I
- TRIAL NECK for Exacta S Rasp - Mark S - Standard — Permedica S.p.A · Class IIa
- INSTRUMENT — Howmedica Osteonics Corp. · Class II
- MultiPolar® — Zimmer, Inc. · Class I
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 73fe5309-db82-4013-97ee-3df06bae9ce3 34 fields · synced May 31, 2026