FDA UDI
In Commercial Distribution
🇺🇸 United States
HONOUR™ Spacer System
DI: 00889929025871
·
Model: I35-10XL-12-10-NS
·
NEXXT SPINE, LLC
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HONOUR™ Spacer System
- Primary DI
- 00889929025871
- Version / Model
- I35-10XL-12-10-NS
- Company Name
- NEXXT SPINE, LLC
- Labeler DUNS
- 003489810
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-27
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 9fba70e3-b131-4309-ad19-67eb40d49f6a
Device Description
Cervical Trial, 10°, No Stop, 16x18x12
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Orthopedic | 888.3080 | 2 |
| 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 |
|---|---|---|---|---|
| 44759 | General internal orthopaedic fixation system implantation kit | A collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00889929025871 | GS1 |
Customer Contacts
- Phone
- 317-436-7801
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K120345 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Angle | 10 | degree | |
| Height | 12 | Millimeter | |
| Width | 18 | Millimeter | |
| Depth | 16 | Millimeter | |
| Device Size Text, specify | No Stop |