Identity
- Trade Name
- Leith Medical MTP Plating System FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- 70mm 0° MTP Plate Right FDA UDI
- Model / Reference
- 0800-2070 FDA UDI
- Description
- 70mm 0° MTP Plate Right FDA UDI
Identifiers
- Primary DI / UDI-DI
- B953080020700 FDA UDI
- 510(k) Number
- K200062 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
Single Use
Yes
Implantable
Yes
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
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Length — 70 Millimeter FDA UDIAngle — 0 degree FDA UDI
Category: Orthopaedic fixation plate, non-bioabsorbable
The Leith Medical MTP Plating System is a non-bioabsorbable, non-customized orthopaedic fixation plate designed to stabilize fractured bones and fuse joints for effective treatment. Made from a firm, implantable sheet intended to be fixed in place with screws, this device facilitates bone healing and provides long-term stability.
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Cleared under the same submission
K200062 also covers:
- Leith Medical 2.7mm Cortical Screw — Leith Medical LLC
- Leith Medical 2.7mm Cortical Screw — Leith Medical LLC
- Leith Medical 2.7mm Cortical Screw — Leith Medical LLC
- Leith Medical 2.7mm Cortical Screw — Leith Medical LLC
- Leith Medical 2.7mm Cortical Screw — Leith Medical LLC
- Leith Medical 2.7mm Cortical Screw — Leith Medical LLC
- Leith Medical 2.7mm Cortical Screw — Leith Medical LLC
- Leith Medical 2.7mm Cortical Screw — Leith Medical LLC
- Leith Medical 3.5mm Cortical Screw — Leith Medical LLC
- Leith Medical 3.5mm Cortical Screw — Leith Medical LLC
- Leith Medical 3.5mm Cortical Screw — Leith Medical LLC
- Leith Medical 3.5mm Cortical Screw — Leith Medical LLC
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
- Leith Medical LLC
Sources (1)
- FDA UDI acde94e9-33d6-4fb6-87b8-83b9e8bd1354 36 fields · synced Jul 25, 2026