FDA UDI
In Commercial Distribution
🇺🇸 United States
3.5mm Cortical Locking Screw, 40mm
DI: 00816101010080
·
Model: NA
·
TOBY ORTHOPAEDICS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- 3.5mm Cortical Locking Screw, 40mm
- Primary DI
- 00816101010080
- Version / Model
- NA
- Catalog Number
- TO-35-CLS-40
- Company Name
- TOBY ORTHOPAEDICS
- Labeler DUNS
- 024163331
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-07
- Public Version
- 4
- Public Version Date
- 2025-02-06
- Public Version Status
- Update
- Public Device Record Key
- 6e1ddb34-7eff-4b92-971e-ad28ef7ee8fe
Device Description
The titanium alloy cortical locking screws are used to affix the plate to the humerus. The screws are 3.5mm diameter and are available in various lengths from 20mm to 45mm.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HWC | Screw, Fixation, Bone | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66947 | Orthopaedic bone screw (non-sliding) | A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816101010080 | GS1 |
Customer Contacts
- Phone
- 305-665-8699
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K081608 | 000 |