Identity
- Trade Name
- ORTHOLOC 3Di FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable, non-sterile FDA UDI
- Model / Reference
- 58190006 FDA UDI
Identifiers
- Catalog Number
- 58190006 FDA UDI
- Primary DI / UDI-DI
- 00840420123343 FDA UDI
- FDA Product Code
- HRS 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 UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Orthopaedic fixation plate, non-bioabsorbable, non-sterile
The ORTHOLOC 3Di is a non-sterile, non-bioabsorbable orthopaedic fixation plate designed for the treatment of traumatic or pathological fractures. This device is intended to be sterilized prior to use and is typically used in conjunction with screws to bridge and stabilize fractured long bone fragments.
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Authorization Coverage (1 country)
Regulatory Authorizations
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
- Wright Medical Technology, Inc.
Sources (1)
- FDA UDI 0f25073b-57e8-4dcf-977e-2104d90a1dee 34 fields · synced Jul 11, 2026