FDA UDI
In Commercial Distribution
🇺🇸 United States
Titan™ Total Shoulder System
DI: 10381780120643
·
Model: SEM095002514
·
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
- 10381780120643
- Version / Model
- SEM095002514
- Catalog Number
- STEM-0950-025-14
- 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
- 9f91437b-c1fc-41c9-909a-d81bebbbc4d3
- Distribution End Date
- 2026-12-31
Device Description
The Titan Modular Total Shoulder cemented stem is shaped to provide proximal fixation. This stem is smooth and fluted, allowing for cement fixation and rotational control. It has 5 stem diameters ranging from 6-14 mm to address varying humeral sizes. The cemented stem is tapered and polished for ease of insertion.
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 |
|---|---|---|---|---|
| 62467 | Surgical soft-tissue manipulation forceps, alligator, reusable | A long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures [typically during ear/nose/throat (ENT) surgery]; it is not intended for insertion through an endoscope, nor into the eye, and is not a dedicated biopsy device. Commonly referred to as alligator- or crocodile-forceps, it has a slender body (to allow for restricted access) and small grasping blades which are hinged close to the distal (working) end. It is a metallic device available in various sizes/lengths; some types may include an integrated suction channel. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10381780120643 | GS1 | ||||
| Secondary | M268STEM0950025141 | HIBCC |
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 | 3.86 in L x .550 in dia; Size 14 |