Identity
- Trade Name
- G7 APICAL HOLE PLUG FDA UDI
- Generic Name
- Acetabulum prosthesis hole plug FDA UDI
- Model / Reference
- 010000994 FDA UDI
Identifiers
- Catalog Number
- 010000994 FDA UDI
- Primary DI / UDI-DI
- 00880304527423 FDA UDI
- 510(k) Number
- K121874 FDA UDI
- FDA Product Code
- OQH FDA UDIOQG FDA UDIOQI FDA UDIPBI FDA UDILPH FDA UDIJDI FDA UDILZO FDA UDILWZ FDA UDI
- GMDN Term
- Acetabulum prosthesis hole plug FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3350 FDA UDI888.3358 FDA UDI888.3353 FDA UDI888.3310 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: Acetabulum prosthesis hole plug
G7 Apical Hole Plug by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Acetabulum prosthesis hole plug.
- plug — implantcast GmbH · Class II
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- Continuum® — Zimmer, Inc. · Class II
- ORTHOLOC™ 2 Jones Fracture System — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- Converge® — Zimmer, Inc. · Class II
- R3 — Smith & Nephew, Inc. · Class II
- Logical Hole Cover — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
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 216df1a3-0e1a-49cd-b784-b2506789d1a2 35 fields · synced May 30, 2026