Identity
- Trade Name
- EXPLOR FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile FDA UDI
- Model / Reference
- IFE-112000 FDA UDI
Identifiers
- Catalog Number
- IFE-112000 FDA UDI
- Primary DI / UDI-DI
- 00880304648548 FDA UDI
- 510(k) Number
- K110201 FDA UDI
- FDA Product Code
- HRS FDA UDIHWC FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
MR Conditional FDA UDI
Category: Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Explor by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K110201 also covers:
- EXPLOR — Biomet Orthopedics, Inc.
- EXPLOR — Biomet Orthopedics, Inc.
- EXPLOR — Biomet Orthopedics, Inc.
- EXPLOR — Biomet Orthopedics, Inc.
- EXPLOR — Biomet Orthopedics, Inc.
- EXPLOR — Biomet Orthopedics, Inc.
- EXPLOR — Biomet Orthopedics, Inc.
- EXPLOR — Biomet Orthopedics, Inc.
- EXPLOR — Biomet Orthopedics, Inc.
- EXPLOR — Biomet Orthopedics, Inc.
- EXPLOR — Biomet Orthopedics, Inc.
- EXPLOR — 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 ffe006d2-1718-4805-aab8-f917c35f62a5 36 fields · synced May 30, 2026