FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Z-Clamp ISP System
K Number: K161016
·
Decision Oct 19, 2016
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
47
Applicant Total
15
Review Days
191
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
- Z-Clamp ISP System
- K Number
- K161016
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zavation, LLC
- Date Received
- April 11, 2016
- Decision Date
- October 19, 2016
- Product Code
- PEK
- 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 |
|---|---|---|---|
| PEK | Spinous Process Plate | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PEK), ordered by most recent decision date.
Minuteman® G6 MIS Fusion Plate
FDA 510(k)
FDA Class 2
·Orthopedic
Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3
FDA 510(k)
FDA Class 2
·Orthopedic
Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion Plate
FDA 510(k)
FDA Class 2
·Orthopedic
KeyLift Expandable Interlaminar Stabilization System
FDA 510(k)
FDA Class 2
·Orthopedic
primaLOK SP Interspinous Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
Huvex Interspinous Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Zavation, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K162206 | Zavation IBF | Apr 4, 2017 | Substantially Equivalent |
| K162575 | Z-LINKPC System | Mar 3, 2017 | Substantially Equivalent |
| K162824 | Z-Span Plate System | Feb 17, 2017 | Substantially Equivalent |
| K153404 | Zavation Spinal System | Apr 21, 2016 | Substantially Equivalent |
| K160362 | Z-Span Plate System | Mar 22, 2016 | Substantially Equivalent |
| K142392 | Zavation Posterior LEIF | Apr 29, 2015 | Substantially Equivalent |
| K142271 | Zavation Z-Link Lumbar | Dec 19, 2014 | Substantially Equivalent |
| K141419 | ZVPLASTY | Sep 12, 2014 | Substantially Equivalent |
| K141005 | Z-LINK CERVICAL | Aug 7, 2014 | Substantially Equivalent |
| K130030 | ZAVATION CERVICAL PLATE SYSTEM | Apr 25, 2013 | Substantially Equivalent |