FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REDEMPTION Beaming System
K Number: K221342
·
Decision Dec 13, 2022
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
17
Review Days
218
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Basic Information
- Device Name
- REDEMPTION Beaming System
- K Number
- K221342
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vilex, LLC
- Date Received
- May 9, 2022
- Decision Date
- December 13, 2022
- Product Code
- HWC
- 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | FDA class 2 | Orthopedic |
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Other Clearances by Vilex, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K260900 | DYNEX® External Fixation Systems | Apr 17, 2026 | Substantially Equivalent |
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| 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 |
| K231493 | NITINEX Memory Compression Staple | Aug 11, 2023 | Substantially Equivalent |
| K230462 | OPTIX H2 Patient Specific Instrument System | Jul 17, 2023 | Substantially Equivalent |