FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Aequalis™ Fx2
DI: 03700386953262
·
Model: DWH561B
·
TORNIER
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Aequalis™ Fx2
- Primary DI
- 03700386953262
- Version / Model
- DWH561B
- Company Name
- TORNIER
- Labeler DUNS
- 260324876
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-16
- Public Version
- 4
- Public Version Date
- 2018-09-07
- Public Version Status
- Update
- Public Device Record Key
- ba07641a-6356-48f7-a62d-47b83edf1cbf
- Distribution End Date
- 2017-10-25
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| KWS | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED | Orthopedic | 888.3660 | 2 |
| HSD | PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED | Orthopedic | 888.3690 | 2 |
| PHX | shoulder prosthesis, reverse configuration | Orthopedic | 888.3660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33711 | Total reverse shoulder prosthesis | A sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the joint particularly in patients with chronic, longstanding rotator cuff muscle tears, arthritis, and/or humeral fractures unsuccessfully treated by previous surgery. The device reverses normal anatomy so that the head portion of the joint is attached to the scapula and the socket portion is attached to the humerus. It typically includes a humeral stem and glenosphere (head) with body and cup components. The device may include screws for implantation and may be implanted with or without bone cement. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03700386953262 | GS1 |
Customer Contacts
- Phone
- +330476613500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141345 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 42 | Millimeter | |
| Device Size Text, specify | Thickness +6 mm | ||
| Angle | 12.5 | degree |