Identity
- Trade Name
- 5.2mm Cannulated Post, 30mm FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- Titanium alloy posts are used to affix the proximal end of the plate to the proximal end of the humerus. With the aid of fixtures, the posts have the ability to have cross elements inserted perpendicular to the axis of the cortical thread of the post. The head of the post is a threaded locking configuration that accepts an expansion cap screw. The posts are 5.25mm in diameter and are available in 5 lengths ranging from 30mm to 50mm. They are cannulated i.e a K-wire can pass through the post longitudinally. FDA UDI
- Model / Reference
- NA FDA UDI
- Description
- Titanium alloy posts are used to affix the proximal end of the plate to the proximal end of the humerus. With the aid of fixtures, the posts have the ability to have cross elements inserted perpendicular to the axis of the cortical thread of the post. The head of the post is a threaded locking configuration that accepts an expansion cap screw. The posts are 5.25mm in diameter and are available in 5 lengths ranging from 30mm to 50mm. They are cannulated i.e a K-wire can pass through the post longitudinally. FDA UDI
Identifiers
- Catalog Number
- TO-52-CP-30 FDA UDI
- Primary DI / UDI-DI
- 00816101017324 FDA UDI
- 510(k) Number
- K081608 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable 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 fixation plate, non-bioabsorbable
5.2mm Cannulated Post, 30mm by Toby Orthopaedics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- 2.0mm 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 7ff28ea8-ccbf-479c-a281-77df922f5ab1 36 fields · synced Jun 1, 2026