FDA UDI
In Commercial Distribution
🇺🇸 United States
Cervical Interbody Fusion System
DI: 00195860012673
·
Model: AC-TL-6-1011-NS
·
Evolution Spine LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cervical Interbody Fusion System
- Primary DI
- 00195860012673
- Version / Model
- AC-TL-6-1011-NS
- Catalog Number
- AC-TL-6-1011-NS
- Company Name
- Evolution Spine LLC
- Labeler DUNS
- 116940934
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-25
- Public Version
- 1
- Public Version Date
- 2021-06-02
- Public Version Status
- New
- Public Device Record Key
- 1c72acc4-1ff8-48a3-b286-24122be0d898
Device Description
14x16x 10mm, 11mm , 6 Deg Trial - No Stop
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
- Yes
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47807 | Surgical implant/trial-implant/sizer holder, reusable | A hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00195860012673 | GS1 |
Customer Contacts
- Phone
- +1(214)682-8536
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Angle | 6 | degree | |
| Depth | 16 | Millimeter | |
| Width | 14 | Millimeter | |
| Device Size Text, specify | 10-11 mm |