FDA UDI
In Commercial Distribution
🇺🇸 United States
MOBIS II 5°
DI: 04047844016091
·
Model: Lumbar cage, angled
·
SIGNUS Medizintechnik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MOBIS II 5°
- Primary DI
- 04047844016091
- Version / Model
- Lumbar cage, angled
- Catalog Number
- B2L5100929
- Company Name
- SIGNUS Medizintechnik GmbH
- Labeler DUNS
- 344203948
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 6
- Public Version Date
- 2020-02-24
- Public Version Status
- Update
- Public Device Record Key
- a2c98962-33a8-4d30-a58c-266fc3da8c3c
Device Description
The MOBIS II ST Spinal Implants have a hollow, slightly curved frame with areas of an open-pore titanium grid structure. Restoration of the intervertebral space can be achieved by the large selection of implants that, at the same time, offers a high degree of intraoperative flexibility. In addition to straight implants, the MOBIS II ST cage is alos avaible with a 5° lordoctic angle. Due to its design, the implant can be aligned with the anterior curvature of the intervertebral body and so is suited for unilateral, dorsal access (TLIF) in the L2 to S1 region of the spine.
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 |
|---|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | 888.3080 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38161 | Metallic spinal interbody fusion cage | A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04047844016091 | GS1 |
Customer Contacts
- Phone
- +49602391660
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141405 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 10x9x29mm |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 35 Degrees Celsius