FDA UDI
In Commercial Distribution
🇺🇸 United States
Titan™ Total Shoulder System
DI: 10381780123217
·
Model: BOD-0923-020-14SML
·
Ascension Orthopedics, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Titan™ Total Shoulder System
- Primary DI
- 10381780123217
- Version / Model
- BOD-0923-020-14SML
- Catalog Number
- BOD-0923-020-14SML
- Company Name
- Ascension Orthopedics, Inc.
- Labeler DUNS
- 942377524
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-09
- Public Version
- 5
- Public Version Date
- 2023-01-25
- Public Version Status
- Update
- Public Device Record Key
- c1d995ed-a6f2-43b3-8371-ea3ebbe2482c
- Distribution End Date
- 2026-12-31
Device Description
The Titan Modular Total Shoulder primary body is shaped to provide proximal fixation and is designed to accommodate the natural humeral geometry, while providing stable fixation, proximal bone loading and proper head placement.
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
- 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 |
|---|---|---|---|---|
| KWS | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED | Orthopedic | 888.3660 | 2 |
| HSD | PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED | Orthopedic | 888.3690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60512 | Shoulder humeral body prosthesis | A sterile implantable component of a total shoulder prosthesis intended to form a connection between a humeral stem prosthesis and a humeral head prosthesis. It is made of metal [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo)] or titanium (Ti)] and is used in a modular shoulder replacement system. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | M269BOD092302014SML1 | HIBCC | ||||
| Primary | 10381780123217 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142413 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 14 Small |