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 K884163
Device Name ACROMED SPINAL ROD AND SPINAL HOOKS
Applicant
Buckman Co., Inc.
921 Calle Verde
Martinez,  CA  94553
Applicant Contact BROMM, R.N.
Correspondent
Buckman Co., Inc.
921 Calle Verde
Martinez,  CA  94553
Correspondent Contact BROMM, R.N.
Regulation Number888.3050
Classification Product Code
KWP  
Date Received10/04/1988
Decision Date 04/26/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-