FDA UDI
In Commercial Distribution
🇺🇸 United States
Dynesys® Top-Loading System
DI: 00889024285156
·
Model: 01.03916.455
·
Zimmer GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- Dynesys® Top-Loading System
- Primary DI
- 00889024285156
- Version / Model
- 01.03916.455
- Company Name
- Zimmer GmbH
- Labeler DUNS
- 488133448
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2015-10-16
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 6ae84dd3-dac3-4aaf-a7d3-6406aac01460
Device Description
DTL Cann. Pedicle+Set screw 6.4x55
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
- 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 |
|---|---|---|---|---|
| NQP | POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION | Orthopedic | 888.3070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58446 | Spinal dynamic-stabilization system | A sterile bone screw spinal implant assembly intended to be used for spinal dynamic stabilization (i.e., soft stabilization), a surgical method different from spinal fixation in that it allows slight mobility between the unstable vertebral segments in the spine. It consists of a combination of pedicle screws, spacers, and a flexible synthetic polymer cord and titanium (Ti) rods used as the longitudinal member; conventional and specialized surgical instruments may also be included. The system is intended to treat various lumbar, thoracic, and/or sacral spinal instabilities and deformities (e.g., degenerative spondylolisthesis, pseudoarthrosis) typically as an adjunct to spinal fusion. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00889024285156 | GS1 | ||||
| Unit of Use | 00889024407855 | GS1 |
Customer Contacts
- Phone
- +1(800)348-2759
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 55 | Millimeter | |
| Outer Diameter | 6.4 | Millimeter |