Spine Innovation Interbody System
- Primary DI
- 00817722020403
- Brand
- Spine Innovation Interbody System
- Company
- SPINE INNOVATION, LLC
- Model
- 90-SDA-123016
- Device description
- Expandable Implant 5° x 12mm W x 16mm H x 30mm L
- Published
- 2017-02-15
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K153356 | 000 | Spine Innovation Interbody System | Spine Innovation, LLC | 2016-01-14 | MAX |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00817722020403 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Polymeric spinal fusion cage, sterile | A sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Disposable devices associated with implantation may be included. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 080376573
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00817722020007 | Spine Innovation Interbody System | 90-SDA-082608 | | 2017-02-15 |
| 00817722020014 | Spine Innovation Interbody System | 90-SDA-083008 | | 2017-02-15 |
| 00817722020021 | Spine Innovation Interbody System | 90-SDA-082609 | | 2017-02-15 |
| 00817722020038 | Spine Innovation Interbody System | 90-SDA-083009 | | 2017-02-15 |
| 00817722020045 | Spine Innovation Interbody System | 90-SDA-082610 | | 2017-02-15 |
| 00817722020052 | Spine Innovation Interbody System | 90-SDA-083010 | | 2017-02-15 |
| 00817722020069 | Spine Innovation Interbody System | 90-SDA-082616 | | 2017-02-15 |
| 00817722020076 | Spine Innovation Interbody System | 90-SDA-092610 | | 2017-02-15 |
| 00817722020083 | Spine Innovation Interbody System | 90-SDA-093010 | | 2017-02-15 |
| 00817722020090 | Spine Innovation Interbody System | 90-SDA-092611 | | 2017-02-15 |
| 00817722020106 | Spine Innovation Interbody System | 90-SDA-093011 | | 2017-02-15 |
| 00817722020113 | Spine Innovation Interbody System | 90-SDA-002611 | | 2017-02-15 |
| 00817722020120 | Spine Innovation Interbody System | 90-SDA-003011 | | 2017-02-15 |
| 00817722020137 | Spine Innovation Interbody System | 90-SDA-002612 | | 2017-02-15 |
| 00817722020144 | Spine Innovation Interbody System | 90-SDA-003012 | | 2017-02-15 |
| 00817722020151 | Spine Innovation Interbody System | 90-SDA-012612 | | 2017-02-15 |
| 00817722020168 | Spine Innovation Interbody System | 90-SDA-013012 | | 2017-02-15 |
| 00817722020175 | Spine Innovation Interbody System | 90-SDA-012613 | | 2017-02-15 |
| 00817722020182 | Spine Innovation Interbody System | 90-SDA-013013 | | 2017-02-15 |
| 00817722020199 | Spine Innovation Interbody System | 90-SDA-022613 | | 2017-02-15 |
Other Devices Sharing Product Codes