FDA UDI
In Commercial Distribution
🇺🇸 United States
ALLY™ Bone Screw-L 10mm
DI: 00852776006300
·
Model: PD-32-601
·
PROVIDENCE MEDICAL TECHNOLOGY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ALLY™ Bone Screw-L 10mm
- Primary DI
- 00852776006300
- Version / Model
- PD-32-601
- Catalog Number
- PD-32-601
- Company Name
- PROVIDENCE MEDICAL TECHNOLOGY, INC.
- Labeler DUNS
- 969820245
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-27
- Public Version
- 8
- Public Version Date
- 2024-01-03
- Public Version Status
- Update
- Public Device Record Key
- 93e9b764-d96c-442a-8a55-d124952401da
Device Description
The bone screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device. Screws are intended for single use only.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation 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 |
|---|---|---|---|---|
| 46651 | Spinal bone screw, non-bioabsorbable | A small, threaded, implantable rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10852776006307 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 00852776006300 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121713 | 000 |