Identity
- Trade Name
- Leith Medical 2.7mm Cortical Screw FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- 2.7mm Cortical Screw 38mm Long FDA UDI
- Model / Reference
- 1027-0038 FDA UDI
- Description
- 2.7mm Cortical Screw 38mm Long FDA UDI
Identifiers
- Primary DI / UDI-DI
- B953102700380 FDA UDI
- 510(k) Number
- K200062 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 2.7 Millimeter FDA UDILength — 38 Millimeter FDA UDI
Category: Orthopaedic bone screw (non-sliding)
Leith Medical 2.7mm Cortical Screw by Leith Medical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic bone screw (non-sliding).
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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 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
- 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 |
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Manufacturer
- Manufacturer
- Leith Medical LLC
Sources (1)
- FDA UDI 31410769-df5b-416e-bc18-0ffe9c77c098 36 fields · synced May 30, 2026