FDA UDI
In Commercial Distribution
🇺🇸 United States
FX Solutions
DI: 03701037301814
·
Model: PRCT2 SIZE 08 CEMENTLESS
·
FX SOLUTIONS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FX Solutions
- Primary DI
- 03701037301814
- Version / Model
- PRCT2 SIZE 08 CEMENTLESS
- Catalog Number
- 311-0208
- Company Name
- FX SOLUTIONS
- Labeler DUNS
- 263076196
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-09
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 1fe8053a-9221-4cb3-8b64-374d6e3b163c
Device Description
Humelock II Cementless Shoulder System PRCT II HUMERAL PLATE TA6V LEFT 4 HOLES
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 |
|---|---|---|---|---|
| 35670 | Total shoulder prosthesis | A sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes glenoid and humeral (head and stem) components typically with parts made of metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03701037301814 | GS1 |
Customer Contacts
- Phone
- +33 474553556
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130759 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 80.5 | Millimeter | |
| Outer Diameter | 8 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store away from light and sunlight. Store away from moisture