FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Athena II Cervical Plate System
K Number: K183409
·
Decision Feb 11, 2019
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
19
Review Days
63
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Basic Information
- Device Name
- Athena II Cervical Plate System
- K Number
- K183409
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medyssey USA, Inc.
- Date Received
- December 10, 2018
- Decision Date
- February 11, 2019
- Product Code
- KWQ
- 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWQ), ordered by most recent decision date.
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Other Clearances by Medyssey USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K232218 | Zenius Spinal System | Aug 24, 2023 | Substantially Equivalent |
| K230301 | Athena III Cervical Plate System | Mar 7, 2023 | Substantially Equivalent |
| K223654 | Medussa-PL Cage | Dec 28, 2022 | Substantially Equivalent |
| K200283 | Medussa-PL Cage | Jun 18, 2020 | Substantially Equivalent |
| K183407 | Triton Cage | Aug 30, 2019 | Substantially Equivalent |
| K181978 | Zenius, Iliad and Kora Spinal Fixation Systems | Aug 13, 2018 | Substantially Equivalent |
| K180022 | Athena Cervical Plate System | Jul 20, 2018 | Substantially Equivalent |
| K170389 | TAURUS PEEK Cage System | Dec 14, 2017 | Substantially Equivalent |
| K172756 | Varian cage | Dec 8, 2017 | Substantially Equivalent |
| K170341 | Medussa-PL Cage | Nov 2, 2017 | Substantially Equivalent |