Identity
- Trade Name
- Tandry Compression Screw System FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- 2.0mm Compression Pin, 7mm FDA UDI
- Model / Reference
- T0415-007 FDA UDI
- Description
- 2.0mm Compression Pin, 7mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719873105175 FDA UDI
- 510(k) Number
- K220359 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic bone screw (non-sliding)
Tandry Compression Screw System by Microware Precision Co., Ltd. — 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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- 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
K220359 also covers:
- Tandry Compression Screw System — MICROWARE PRECISION CO., LTD.
- Tandry Compression Screw System — MICROWARE PRECISION CO., LTD.
- Tandry Compression Screw System — MICROWARE PRECISION CO., LTD.
- Tandry Compression Screw System — MICROWARE PRECISION CO., LTD.
- Tandry Compression Screw System — MICROWARE PRECISION CO., LTD.
- Tandry Compression Screw System — MICROWARE PRECISION CO., LTD.
- Tandry Compression Screw System — MICROWARE PRECISION CO., LTD.
- Tandry Compression Screw System — MICROWARE PRECISION CO., LTD.
- Tandry Compression Screw System — MICROWARE PRECISION CO., LTD.
- Tandry Compression Screw System — MICROWARE PRECISION CO., LTD.
- Tandry Compression Screw System — MICROWARE PRECISION CO., LTD.
- Tandry Compression Screw System — MICROWARE PRECISION CO., LTD.
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
- Microware Precision Co., Ltd.
Sources (1)
- FDA UDI dcea1391-7b1f-4eb2-9a8d-76cc63018b13 35 fields · synced Jun 8, 2026