FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES CATALOGUE NUMBERS
K Number: K010776
·
Decision Apr 6, 2001
Classifications
1
FEI Numbers
326
Registration Numbers
326
Same Product Code
308
Applicant Total
57
Review Days
23
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
- TRINITY POLYAXIAL SCREW, MEHDIAN SPINAL ROD (6MM), MODEL 159.XXX SERIES CATALOGUE NUMBERS
- K Number
- K010776
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Corin USA
- Date Received
- March 14, 2001
- Decision Date
- April 6, 2001
- 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 Corin USA
| K Number | Device Name | ||
|---|---|---|---|
| K203751 | OMNIVision system | Apr 12, 2021 | Substantially Equivalent |
| K202805 | Optimized Positioning System (OPS) Insight | Nov 20, 2020 | Substantially Equivalent |
| K193545 | Corin Optimized Positioning System (OPS) Femoral | Aug 4, 2020 | Substantially Equivalent |
| K193042 | Optimized Positioning System (OPS) ReView | Jun 26, 2020 | Substantially Equivalent |
| K192656 | Optimized Positioning System (OPS) Insight | May 1, 2020 | Substantially Equivalent |
| K190143 | LARS AC Band Device | Nov 4, 2019 | Substantially Equivalent |
| K190834 | Corin Optimized Position System Functional Hip Analysis (OPS FHA) | Jul 22, 2019 | Substantially Equivalent |
| K183038 | Corin Optimized Positioning System (OPS) Plan | Nov 26, 2018 | Substantially Equivalent |
| K181061 | Corin Optimized Positioning System (OPS) Femoral | Sep 7, 2018 | Substantially Equivalent |
| K152893 | Corin Optimized Positioning System (OPS) | Jun 3, 2016 | Substantially Equivalent |