FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SeaSpine Spacer System - Redondo™
DI: 10889981044367
·
Model: 36-2810
·
SEASPINE ORTHOPEDICS CORPORATION
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SeaSpine Spacer System - Redondo™
- Primary DI
- 10889981044367
- Version / Model
- 36-2810
- Catalog Number
- 36-2810
- Company Name
- SEASPINE ORTHOPEDICS CORPORATION
- Labeler DUNS
- 079840876
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 56612427-f4d8-47a1-ba80-c3a6b222e898
- Distribution End Date
- 2016-09-02
Device Description
Redondo Implant 26mm x 24mm x 10mm, 8 Deg
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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| MQP | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE | Orthopedic | 888.3060 | 2 |
| MAX | Intervertebral fusion device with bone graft, lumbar | Orthopedic | 888.3080 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57806 | Vertebral body prosthesis, non-sterile | A non-sterile implantable device designed to replace or repair (fuse) the spinal bony segments, or vertebrae, lost or injured as a consequence of, e.g., trauma, deformity, tumour, or degenerative disease. It is typically intended to be used with supplemental spinal fixation and may be used with a bone graft. It is usually made of metal, polymer, or a combination of these materials. This device must be sterilized prior to use. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10889981044367 | GS1 |
Customer Contacts
- Phone
- +1(866)942-8698
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K082310 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 26mm x 24mm x 10mm, 8° |