Identity
- Trade Name
- Leith Medical 3.5mm Cortical Screw FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- 3.5mm Cortical Screw 18mm Long FDA UDI
- Model / Reference
- 1035-0018 FDA UDI
- Description
- 3.5mm Cortical Screw 18mm Long FDA UDI
Identifiers
- Primary DI / UDI-DI
- B953103500180 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 — 3.5 Millimeter FDA UDILength — 18 Millimeter FDA UDI
Category: Orthopaedic bone screw (non-sliding)
Leith Medical 3.5mm Cortical Screw by Leith Medical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw (non-sliding).
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- Arthrex® — Arthrex, Inc. · Class II
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- STARDRIVE — Synthes GmbH · Class IIb
- Arthrex® — Arthrex, Inc. · Class II
- Cancellous Screw, Locking — I.T.S. GmbH · Class II
- PANGEA — Stryker Corp. · Class II
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 d3b68558-4b6f-4160-b700-6f3d3183cfc5 36 fields · synced May 31, 2026