Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K203205
Device Name Navigated Spine Instruments
Applicant
Stryker Spine
600 Hope Pkwy. SE
Leesburg,  VA  20175
Applicant Contact Megan Callanan
Correspondent
Stryker Spine
600 Hope Pkwy. SE
Leesburg,  VA  20175
Correspondent Contact Megan Callanan
Regulation Number882.4560
Classification Product Code
OLO  
Date Received10/30/2020
Decision Date 03/23/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-