Identity
- Trade Name
- 2.7mm T10 Drive Cortical Locking Screw, 28mm FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- The titanium alloy cortical locking screws (torx T-10 head) are used to affix the plate to the bone. The screws are 2.7mm in diameter and are available in various lengths from 10mm to 34mm. FDA UDI
- Model / Reference
- NA FDA UDI
- Description
- The titanium alloy cortical locking screws (torx T-10 head) are used to affix the plate to the bone. The screws are 2.7mm in diameter and are available in various lengths from 10mm to 34mm. FDA UDI
Identifiers
- Catalog Number
- TO-27-T10-CLS-28 FDA UDI
- Primary DI / UDI-DI
- 00816101017690 FDA UDI
- 510(k) Number
- K081608 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
No
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
Category: Orthopaedic bone screw (non-sliding)
2.7mm T10 Drive Cortical Locking Screw, 28mm by Toby Orthopaedics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw (non-sliding).
- EVOS — Smith & Nephew, Inc. · Class II
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- Zavation — ZAVATION · Class II
- 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
K081608 also covers:
- 2.0mm Cross Element, 25mm — TOBY ORTHOPAEDICS
- 2.0mm Cross Element, 30mm — TOBY ORTHOPAEDICS
- 2.0mm Cross Element, 35mm — TOBY ORTHOPAEDICS
- 2.7mm T10 Drive Bypass Cortical Locking Screw, 10mm — TOBY ORTHOPAEDICS
- 2.7mm T10 Drive Bypass Cortical Locking Screw, 12mm — TOBY ORTHOPAEDICS
- 2.7mm T10 Drive Bypass Cortical Locking Screw, 14mm — TOBY ORTHOPAEDICS
- 2.7mm T10 Drive Bypass Cortical Locking Screw, 16mm — TOBY ORTHOPAEDICS
- 2.7mm T10 Drive Bypass Cortical Locking Screw, 18mm — TOBY ORTHOPAEDICS
- 2.7mm T10 Drive Bypass Cortical Locking Screw, 20mm — TOBY ORTHOPAEDICS
- 2.7mm T10 Drive Bypass Cortical Locking Screw, 22mm — TOBY ORTHOPAEDICS
- 2.7mm T10 Drive Bypass Cortical Locking Screw, 28mm — TOBY ORTHOPAEDICS
- 2.7mm T10 Drive Bypass Cortical Locking Screw, 30mm — TOBY ORTHOPAEDICS
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
- Toby Orthopaedics
Sources (1)
- FDA UDI f1d731b1-7fd8-4818-a289-a9951ae888da 36 fields · synced May 30, 2026