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 Manipulator, Plunger-Like Joint
510(k) Number K946258
Device Name MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT
Applicant
Spinalight, Inc.
320-A Bell Park Dr.
Woodstock,  GA  30188
Applicant Contact T A COX
Correspondent
Spinalight, Inc.
320-A Bell Park Dr.
Woodstock,  GA  30188
Correspondent Contact T A COX
Classification Product Code
LXM  
Date Received12/06/1994
Decision Date 11/20/1995
Decision Substantially Equivalent (SESE)
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-