FDA UDI
In Commercial Distribution
🇺🇸 United States
EVOLUTION
DI: 00192629298293
·
Model: E615XRCM
·
Microport Orthopedics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- EVOLUTION
- Primary DI
- 00192629298293
- Version / Model
- E615XRCM
- Catalog Number
- E615XRCM
- Company Name
- Microport Orthopedics Inc.
- Labeler DUNS
- 079118736
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-19
- Public Version
- 1
- Public Version Date
- 2025-05-27
- Public Version Status
- New
- Public Device Record Key
- dd21a958-d08d-4879-bb21-d6f589d7591d
Device Description
EVOLUTION HINGE TIB CM XR TEMPLATES 15% MAG
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HWT | TEMPLATE | Orthopedic | 888.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13180 | Orthopaedic prosthesis implantation positioning instrument, reusable | A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. 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 |
|---|---|---|---|---|---|---|
| Secondary | M684E615XRCM1 | HIBCC | ||||
| Primary | 00192629298293 | GS1 |
Customer Contacts
- Phone
- +1(866)872-0211
- [email protected]