• 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 K210457
Device Name 7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & Key
Applicant
7D Surgical Inc.
60 scarsdale road, unit 118
toronto,  CA m3b 2r7
Applicant Contact daniel zisind
Correspondent
7D Surgical Inc.
60 scarsdale road, unit 118
toronto,  CA m3b 2r7
Correspondent Contact daniel ziskind
Regulation Number882.4560
Classification Product Code
OLO  
Date Received02/16/2021
Decision Date 06/21/2021
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-