FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System
K Number: K143163
·
Decision Jan 26, 2015
Classifications
1
FEI Numbers
253
Registration Numbers
253
Same Product Code
200
Applicant Total
81
Review Days
84
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
- AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System
- K Number
- K143163
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3080
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Corporation
- Date Received
- November 3, 2014
- Decision Date
- January 26, 2015
- Product Code
- OVD
- 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 |
|---|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OVD), ordered by most recent decision date.
Anteralign LS coverplate
FDA 510(k)
FDA Class 2
·Orthopedic
MectaLIF 3D Metal Anterior
FDA 510(k)
FDA Class 2
·Orthopedic
SCRIPT Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
Ventana A Anterior Lumbar Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
DeGen Medical Patient Specific Implant (PSI) System
FDA 510(k)
FDA Class 2
·Orthopedic
IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Stryker Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K232157 | Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control | Aug 18, 2023 | Substantially Equivalent |
| K223770 | Sonopet 1Q 3 7cm 1Q Large | Feb 16, 2023 | Substantially Equivalent |
| K212194 | Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System | Feb 16, 2023 | Substantially Equivalent |
| K221728 | Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran Anterior Cervical Plating (ACP) System, Reflex Hybrid ACP System, UniVise Spinous Process Fixation Plate | Oct 19, 2022 | Substantially Equivalent |
| K221074 | OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device | Sep 16, 2022 | Substantially Equivalent |
| K221098 | Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit | Jul 12, 2022 | Substantially Equivalent |
| K213824 | Sonopet iQ Ultrasonic Aspirator System | Feb 3, 2022 | Substantially Equivalent |
| K212055 | Connected OR Hub with Device and Voice Control | Dec 16, 2021 | Substantially Equivalent |
| K210377 | Stryker iBur hubs and cutting accessories | Jun 30, 2021 | Substantially Equivalent |
| K202964 | iBed Wireless with iBed Mobile | Jun 18, 2021 | Substantially Equivalent |