FDA UDI
In Commercial Distribution
🇺🇸 United States
2.0mm Cross Element, 30mm
DI: 00816101010189
·
Model: NA
·
TOBY ORTHOPAEDICS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- 2.0mm Cross Element, 30mm
- Primary DI
- 00816101010189
- Version / Model
- NA
- Catalog Number
- TO-20-CE-30
- 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
- 55b8d978-f335-43de-bfa9-e88b2e3389a0
Device 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.
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 | 00816101010189 | GS1 |
Customer Contacts
- Phone
- 305-665-8699
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K081608 | 000 |