FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NITINEX Memory Compression Staple
K Number: K231493
·
Decision Aug 11, 2023
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
230
Applicant Total
17
Review Days
80
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- NITINEX Memory Compression Staple
- K Number
- K231493
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vilex, LLC
- Date Received
- May 23, 2023
- Decision Date
- August 11, 2023
- Product Code
- JDR
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JDR | Staple, Fixation, Bone | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JDR), ordered by most recent decision date.
Linkt Compression Staple System
FDA 510(k)
FDA Class 2
·Orthopedic
Medline UNITE® REFLEX® Hybrid Nitinol Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
Arthrex DynaNite Nitinol Staples
FDA 510(k)
FDA Class 2
·Orthopedic
TMC Compression Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
TMC Compression Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
COGNiTiON Staple System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Vilex, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K260900 | DYNEX® External Fixation Systems | Apr 17, 2026 | Substantially Equivalent |
| K250304 | TITANEX Screw Systems | Mar 5, 2025 | Substantially Equivalent |
| K240475 | Hintermann Series H2 Total Ankle System | Dec 2, 2024 | Substantially Equivalent |
| K243408 | TACTIX Vector Syndesmosis System | Nov 27, 2024 | Substantially Equivalent |
| K233816 | REDEMPTION Charcot Plating System | Aug 28, 2024 | Substantially Equivalent |
| K240035 | TACTIX Vector Syndesmosis System | Aug 1, 2024 | Substantially Equivalent |
| K231343 | Redemption Duo Hindfoot Nail System | Jan 30, 2024 | Substantially Equivalent |
| K231504 | TITANEX MICROBEAM Screw System, TITANEX ARTEMIS Screw System | Sep 11, 2023 | Substantially Equivalent |
| K230462 | OPTIX H2 Patient Specific Instrument System | Jul 17, 2023 | Substantially Equivalent |
| K230204 | ALPHALOK Plating System | Apr 25, 2023 | Substantially Equivalent |