FDA UDI
In Commercial Distribution
🇺🇸 United States
Fuse ULTRA Foot plating System
DI: B565OS4230191
·
Model: OS423019
·
CPM Medical Consultants, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Fuse ULTRA Foot plating System
- Primary DI
- B565OS4230191
- Version / Model
- OS423019
- Catalog Number
- OS423019
- Company Name
- CPM Medical Consultants, LLC
- Labeler DUNS
- 017138000
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-28
- Public Version
- 2
- Public Version Date
- 2025-03-19
- Public Version Status
- Update
- Public Device Record Key
- 40a057fa-7c97-4eba-8b73-87cbd61c9f05
Device Description
Small Compressor Distractor Assembly
Device Characteristics
- Single Use
- No
- 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 Safe
- 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 |
|---|---|---|---|---|
| 61802 | Bone tap, reprocessed | A sterile, metal, surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end, and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached, whereby it will typically be manually rotated. This is a previously used single-use device that has been processed for an additional single-use patient application. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B565OS4230191 | HIBCC |
Customer Contacts
- Phone
- 972-331-5860
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141784 | 000 |