Identity
- Trade Name
- G7 DUAL MOBILITY FDA UDI
- Generic Name
- Femoral head prosthesis trial FDA UDI
- Model / Reference
- 110026614 FDA UDI
Identifiers
- Catalog Number
- 110026614 FDA UDI
- Primary DI / UDI-DI
- 00880304734951 FDA UDI
- 510(k) Number
- K150522 FDA UDI
- FDA Product Code
- LZO FDA UDIKWY FDA UDIOQG FDA UDILPH FDA UDI
- GMDN Term
- Femoral head prosthesis trial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3390 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Femoral head prosthesis trial
G7 Dual Mobility by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Femoral head prosthesis trial.
- Modal Total Hip System — MODAL MANUFACTURING LLC · Class II
- CHARNLEY — DEPUY INTERNATIONAL LTD · Class I
- Klassic Femoral Head Trial — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- AcuMatch — Exactech, Inc. · Class I
- AcuMatch — Exactech, Inc. · Class I
- NovoHip Total Hip System — Novosource, Inc. · Class II
- INSTRUMENT — Howmedica Osteonics Corp. · Class II
- Trail Head — ADLER ORTHO SPA · Class I
Cleared under the same submission
K150522 also covers:
- Active Articulation — Biomet Orthopedics, Inc.
- Active Articulation — Biomet Orthopedics, Inc.
- Active Articulation™ Dual Mobility — Biomet Orthopedics, Inc.
- Active Articulation™ Dual Mobility — Biomet Orthopedics, Inc.
- G7 DUAL MOBILITY — Biomet Orthopedics, Inc.
- G7® Dual Mobility — Biomet Orthopedics, Inc.
- G7® Dual Mobility — Biomet Orthopedics, Inc.
- G7® Dual Mobility — Biomet Orthopedics, Inc.
- G7® Dual Mobility — Biomet Orthopedics, Inc.
- G7® Dual Mobility — Biomet Orthopedics, Inc.
- G7® Dual Mobility — Biomet Orthopedics, Inc.
- G7® Dual Mobility — 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 b5e74d1f-b3b6-41a4-9509-3d1b239be18a 35 fields · synced Jun 8, 2026