Identity
- Trade Name
- Leith Medical Plating System Instruments FDA UDI
- Generic Name
- Surgical instrument/implant depth limiter, reusable FDA UDI
- Device Name
- Lapidus Plate Trial Left FDA UDI
- Model / Reference
- 0100-Trial FDA UDI
- Description
- Lapidus Plate Trial Left FDA UDI
Identifiers
- Primary DI / UDI-DI
- B9530100TRIAL0 FDA UDI
- 510(k) Number
- K200062 FDA UDI
- FDA Product Code
- HWC FDA UDIHRS FDA UDI
- GMDN Term
- Surgical instrument/implant depth limiter, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Dimensions & Sizes
- Size
- Length — 1.75 Inch FDA UDI
Category: Surgical instrument/implant depth limiter, reusable
Leith Medical Plating System Instruments by Leith Medical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
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
- Leith Medical LLC
Sources (1)
- FDA UDI 425c366d-095c-4639-aad3-0229b1887b87 36 fields · synced Jun 1, 2026