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 Appliance, Fixation, Spinal Interlaminal
510(k) Number K922504
Device Name ISOLA(R) TANDEM CONNECTOR
Applicant
Acromed Corp.
3303 Carnegie Ave.
Cleveland,  OH  44115
Applicant Contact ROSEMARY H ZANG
Correspondent
Acromed Corp.
3303 Carnegie Ave.
Cleveland,  OH  44115
Correspondent Contact ROSEMARY H ZANG
Regulation Number888.3050
Classification Product Code
KWP  
Date Received05/27/1992
Decision Date 05/18/1993
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-