FDA UDI
In Commercial Distribution
🇺🇸 United States
AEQUALIS REVERSED FRACTURE
DI: 03700434023183
·
Model: DWD861
·
TORNIER
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- AEQUALIS REVERSED FRACTURE
- Primary DI
- 03700434023183
- Version / Model
- DWD861
- Catalog Number
- DWD861
- Company Name
- TORNIER
- Labeler DUNS
- 260324876
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-26
- Public Version
- 1
- Public Version Date
- 2024-07-04
- Public Version Status
- New
- Public Device Record Key
- 81f637fc-3858-4865-86f0-d35859a2afd8
Device Description
Humeral Insert
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
- 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
- Yes
- 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 |
| 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 | 03700434023183 | GS1 |
Customer Contacts
- Phone
- +330476613500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K071948 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Lateralized | ||
| Outer Diameter | 36 | Millimeter | |
| Device Size Text, specify | Thickness: +9mm |