Identity
- Trade Name
- 2.0mm Cross Element, 35mm FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- Titanium alloy cross elements are designed to provide additional support to the humeral head by entering the posts perpendicular to the axis of the cortical thread of the posts. FDA UDI
- Model / Reference
- NA FDA UDI
- Description
- Titanium alloy cross elements are designed to provide additional support to the humeral head by entering the posts perpendicular to the axis of the cortical thread of the posts. FDA UDI
Identifiers
- Catalog Number
- TO-20-CE-35 FDA UDI
- Primary DI / UDI-DI
- 00816101010196 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)
2.0mm Cross Element, 35mm by Toby Orthopaedics — 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
K081608 also covers:
- 2.0mm Cross Element, 25mm — TOBY ORTHOPAEDICS
- 2.0mm Cross Element, 30mm — 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
- 2.7mm T10 Drive Cortical Locking Screw, 12mm — 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 21a7309c-136a-42d8-b800-20c502f56a24 36 fields · synced Jun 1, 2026