FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NOVEL SPINAL SYSTEM
K Number: K081153
·
Decision Jan 30, 2009
Classifications
1
FEI Numbers
326
Registration Numbers
326
Same Product Code
308
Applicant Total
12
Review Days
282
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
- NOVEL SPINAL SYSTEM
- K Number
- K081153
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medyssey Co, Ltd.
- Date Received
- April 23, 2008
- Decision Date
- January 30, 2009
- Product Code
- MNH
- 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 |
|---|---|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MNH), ordered by most recent decision date.
Reliance Spinal Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
CastleLoc Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
FixxSure® X-Link
FDA 510(k)
FDA Class 2
·Orthopedic
Spinal fixation system
FDA 510(k)
FDA Class 2
·Orthopedic
ANAX 5.5 Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
HC Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Medyssey Co, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K260036 | NeckTune 3D SA Cervical Cage | Jun 15, 2026 | Substantially Equivalent |
| 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 |