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2.7mm T10 Drive Bypass Cortical Locking Screw, 32mm
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- 2.7mm T10 Drive Bypass Cortical Locking Screw, 32mm FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- The titanium alloy bypass locking screws (torx T-10 head) are designed to affix the plate to the bone using a similar design as the cortical locking screw, except that the screw head includes scallops that allow a second locking screw to be installed in the adjacent hole. The bypass locking screws are 2.7mm in diameter and are available in multiple lengths ranging from 10mm to 34mm FDA UDI
- Model / Reference
- NA FDA UDI
- Description
- The titanium alloy bypass locking screws (torx T-10 head) are designed to affix the plate to the bone using a similar design as the cortical locking screw, except that the screw head includes scallops that allow a second locking screw to be installed in the adjacent hole. The bypass locking screws are 2.7mm in diameter and are available in multiple lengths ranging from 10mm to 34mm FDA UDI
Identifiers
- Catalog Number
- TO-27-T10-BLS-32 FDA UDI
- Primary DI / UDI-DI
- 00816101017843 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 Bypass Cortical Locking Screw, 32mm 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
- TriLeap Lower Extremity Anatomic Plating System — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
- Arthrex® — Arthrex, Inc. · Class II
- 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 cd9e8125-9e19-4935-a959-03030a83c524 36 fields · synced May 30, 2026