Identity
- Trade Name
- G7 BALL HEX DRIVER FOR INSERTER FDA UDI
- Generic Name
- Surgical torque wrench, reusable FDA UDI
- Model / Reference
- 010002736 FDA UDI
Identifiers
- Catalog Number
- 010002736 FDA UDI
- Primary DI / UDI-DI
- 00880304926820 FDA UDI
- 510(k) Number
- K121874 FDA UDI
- FDA Product Code
- KWZ FDA UDIPBI FDA UDIJDI FDA UDIOQG FDA UDIOQI FDA UDILPH FDA UDIOQH FDA UDILZO FDA UDILWZ FDA UDI
- GMDN Term
- Surgical torque wrench, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3310 FDA UDI888.3350 FDA UDI888.3358 FDA UDI888.3353 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: Surgical torque wrench, reusable
G7 Ball Hex Driver For Inserter by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical torque wrench, reusable.
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- IMHS — Smith & Nephew, Inc. · Class II
- OXFORD ANKLE FUSION NAIL(AFN) SYSTEM — ORTHO SOLUTIONS HOLDINGS LIMITED · Class II
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- Matrix — Synthes · Class I
Cleared under the same submission
K121874 also covers:
- Biomet® — Biomet Orthopedics, Inc.
- Biomet® — Biomet Orthopedics, Inc.
- Biomet® — Biomet Orthopedics, Inc.
- Biomet® — Biomet Orthopedics, Inc.
- G7 — Biomet Orthopedics, Inc.
- G7 — Biomet Orthopedics, Inc.
- G7 — Biomet Orthopedics, Inc.
- G7 — Biomet Orthopedics, Inc.
- G7 — Biomet Orthopedics, Inc.
- G7 — Biomet Orthopedics, Inc.
- G7 — Biomet Orthopedics, Inc.
- G7 — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI 820960af-06fb-4595-a0c5-7f70321bfc90 35 fields · synced Jun 8, 2026