FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ENDOSKELETON® TCS
DI: 00191375028345
·
Model: 5210-1017
·
TITAN SPINE, LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ENDOSKELETON® TCS
- Primary DI
- 00191375028345
- Version / Model
- 5210-1017
- Catalog Number
- 5210-1017
- Company Name
- TITAN SPINE, LLC
- Labeler DUNS
- 623316978
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-30
- Public Version
- 4
- Public Version Date
- 2020-12-09
- Public Version Status
- Update
- Public Device Record Key
- 3a044999-4442-4669-a003-f98a98944092
- Distribution End Date
- 2020-09-18
Device Description
Graft Packing & Screw Reference Block
Device Characteristics
- Single Use
- No
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OVE | Intervertebral fusion device with integrated fixation, cervical | Orthopedic | 888.3080 | 2 |
| ODP | Intervertebral fusion device with bone graft, cervical | Orthopedic | 888.3080 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47743 | Bone graft packing block | A device designed to tightly compact (pack) an implant with a bone graft material (e.g., autologous, allogeneic, xenogeneic, or of synthetic origin) prior to the implantation of the implant. It is typically a small, box-shaped device consisting of two parts, a frame to hold the implant to be filled and a fitted lid that stabilizes the implant while it is being filled. The packing of the implant is done manually, typically with an impactor. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00191375028345 | GS1 |
Customer Contacts
- Phone
- +1(262)242-7801
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142940 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 1 | Inch | |
| Width | 2 | Inch | |
| Length | 1.5 | Inch |