FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Medyssey Navigation System
K Number: K242806
·
Decision Apr 16, 2025
Classifications
1
FEI Numbers
381
Registration Numbers
381
Same Product Code
430
Applicant Total
12
Review Days
211
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Basic Information
- Device Name
- Medyssey Navigation System
- K Number
- K242806
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medyssey Co, Ltd.
- Date Received
- September 17, 2024
- Decision Date
- April 16, 2025
- Product Code
- OLO
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | FDA class 2 | Neurology |
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Other Clearances by Medyssey Co, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K260036 | NeckTune 3D SA Cervical Cage | Jun 15, 2026 | Substantially Equivalent |
| K121670 | MEDYSSEY CANNULATED PEDICLE SCREW | Jan 25, 2013 | Substantially Equivalent |
| K121320 | C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE | Aug 10, 2012 | Substantially Equivalent |
| K121246 | MEDYSSY LT CAGE SYSTEM | Jun 15, 2012 | Substantially Equivalent |
| K110284 | NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM | Jun 8, 2011 | Substantially Equivalent |
| K110283 | ZENIUS SPINAL SYSTEM | May 19, 2011 | Substantially Equivalent |
| K110067 | LP CAGE | Apr 8, 2011 | Substantially Equivalent |
| K103272 | ZENIUS SPINAL SYSTEM | Dec 29, 2010 | Substantially Equivalent |
| K103147 | NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM | Dec 16, 2010 | Substantially Equivalent |
| K093104 | MEDYSSEY CO., LTD., ZENIUS SPINAL SYSTEM | Jun 25, 2010 | Substantially Equivalent |