FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
NeckTune 3D SA Cervical Cage
K Number: K260036
·
Decision Jun 15, 2026
Classifications
1
FEI Numbers
230
Registration Numbers
230
Same Product Code
161
Applicant Total
12
Review Days
160
Basic Information
- Device Name
- NeckTune 3D SA Cervical Cage
- K Number
- K260036
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medyssey Co, Ltd.
- Date Received
- January 6, 2026
- Decision Date
- June 15, 2026
- Product Code
- OVE
- 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 |
|---|---|---|---|
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | FDA class 2 | Orthopedic |
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Other Clearances by Medyssey Co, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K242806 | Medyssey Navigation System | Apr 16, 2025 | 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 |