FDA UDI
In Commercial Distribution
🇺🇸 United States
EVOL®ha-C Cervical Interbody System
DI: 00841193120980
·
Model: CES-370
·
Cutting Edge Spine, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EVOL®ha-C Cervical Interbody System
- Primary DI
- 00841193120980
- Version / Model
- CES-370
- Catalog Number
- CES-370
- Company Name
- Cutting Edge Spine, LLC
- Labeler DUNS
- 069472647
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-31
- Public Version
- 1
- Public Version Date
- 2018-10-01
- Public Version Status
- New
- Public Device Record Key
- 32d63620-17a8-4463-9e99-8839b0d6195e
Device Description
EVOL®ha-C Cervical TRIAL 16WX14D 4° 7H-8H
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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61247 | Orthopaedic cement restrictor sizer | A non-sterile, hand-held manual orthopaedic surgical instrument designed to be used to measure the diameter of the medullary canal of a bone (e.g., femur, humerus) in order to select the appropriate size orthopaedic cement restrictor implant. It may be in the form of a trial prosthesis attached to an inserter, or a rod with a measuring gauge at the distal end. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841193120980 | GS1 |
Customer Contacts
- Phone
- +1(704)243-0892 ext. 10
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180674 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 400 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature