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LORRAINE 2.5/3.5mm Medial Distal Humerus Plate, 4 Hole, Left
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- LORRAINE 2.5/3.5mm Medial Distal Humerus Plate, 4 Hole, Left FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Model / Reference
- B-161510 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640187462784 FDA UDI
- 510(k) Number
- K250933 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable 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
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
MR Conditional FDA UDI
Category: Orthopaedic fixation plate, non-bioabsorbable
LORRAINE 2.5/3.5mm Medial Distal Humerus Plate, 4 Hole, Left by Bonebridge AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate, non-bioabsorbable.
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- PŁYTKI DO TWARZOCZASZKI — ChM spółka z ograniczoną odpowiedzialnością · Class IIb
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- ORTHOLOC 3DSi CLAW II — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
Cleared under the same submission
K250933 also covers:
- LORRAINE 2.5/3.5mm Medial Distal Humerus Plate, 10 Hole, Left — Bonebridge AG
- LORRAINE 2.5/3.5mm Medial Distal Humerus Plate, 10 Hole, Right — Bonebridge AG
- LORRAINE 2.5/3.5mm Medial Distal Humerus Plate, 4 Hole, Right — Bonebridge AG
- LORRAINE 2.5/3.5mm Medial Distal Humerus Plate, 6 Hole, Left — Bonebridge AG
- LORRAINE 2.5/3.5mm Medial Distal Humerus Plate, 6 Hole, Right — Bonebridge AG
- LORRAINE 2.5/3.5mm Medial Distal Humerus Plate, 8 Hole, Left — Bonebridge AG
- LORRAINE 2.5/3.5mm Medial Distal Humerus Plate, 8 Hole, Right — Bonebridge AG
- LORRAINE 2.5/3.5mm Posterolateral Distal Humerus Plate, 11 Hole, Left — Bonebridge AG
- LORRAINE 2.5/3.5mm Posterolateral Distal Humerus Plate, 11 Hole, Right — Bonebridge AG
- LORRAINE 2.5/3.5mm Posterolateral Distal Humerus Plate, 5 Hole, Left — Bonebridge AG
- LORRAINE 2.5/3.5mm Posterolateral Distal Humerus Plate, 5 Hole, Right — Bonebridge AG
- LORRAINE 2.5/3.5mm Posterolateral Distal Humerus Plate, 8 Hole, Left — Bonebridge AG
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
- Bonebridge AG
Sources (1)
- FDA UDI 6e8d8e7b-aaff-4654-9cff-d994ba96abac 33 fields · synced May 30, 2026