FDA UDI
In Commercial Distribution
🇺🇸 United States
Pro-fix™ Precision Fixation System
DI: D765PFB1451
·
Model: PFB14-5
·
Osteogenics Biomedical Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- Pro-fix™ Precision Fixation System
- Primary DI
- D765PFB1451
- Version / Model
- PFB14-5
- Company Name
- Osteogenics Biomedical Inc
- Labeler DUNS
- 123853058
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2021-01-22
- Public Version
- 2
- Public Version Date
- 2024-02-19
- Public Version Status
- Update
- Public Device Record Key
- b137dbe6-86d8-4b22-a489-5e275f4cd73f
Device Description
1.5 mm x 14.0 mm self-tapping titanium alloy bone fixation screw
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 Conditional
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| DZL | Screw, Fixation, Intraosseous | Dental | 872.4880 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61837 | Craniofacial bone screw, non-bioabsorbable, non-sterile | A small, non-sterile, threaded rod with a slotted head intended to be implanted or inserted short-term in craniofacial bone (including the maxilla and/or mandible) for fracture treatment or for the fixation of transplanted bone chips and/or small grafts (e.g., during an intraoral bone augmentation procedure). The device may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as surgical steel, titanium (Ti)]. This device is intended to be sterilized prior to use. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | D765PFB1450 | HIBCC | ||||
| Primary | D765PFB1451 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K093719 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 14.0 | Millimeter |