FDA UDI
In Commercial Distribution
🇺🇸 United States
Ortho Solutions Extremity Fixation Implants for Osteosysnthesis
DI: 05055662932720
·
Model: OS310204
·
ORTHO SOLUTIONS HOLDINGS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Ortho Solutions Extremity Fixation Implants for Osteosysnthesis
- Primary DI
- 05055662932720
- Version / Model
- OS310204
- Catalog Number
- OS310204
- Company Name
- ORTHO SOLUTIONS HOLDINGS LIMITED
- Labeler DUNS
- 218648211
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-13
- Public Version
- 6
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- 825ba0f3-40af-4bae-bc7f-ec10d42d0ab9
Device Description
AO QC COMPRESSION SCREW DRILL 12MM
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HRS | Plate, Fixation, Bone | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61235 | Cannulated surgical drill bit, single-use | A metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05055662932713 | GS1 | Cardboard Box | 10 | In Commercial Distribution | |
| Primary | 05055662932720 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111678 | 000 |