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 Screw, Fixation, Bone
510(k) Number K954485
Device Name 6.5MM SOLID CANCELLOUS BONE SCREW
Applicant
Ace Medical Co.
2260 E. El Segundo Blvd.
El Segundo,  CA  90245
Applicant Contact NANCY GIEZEN
Correspondent
Ace Medical Co.
2260 E. El Segundo Blvd.
El Segundo,  CA  90245
Correspondent Contact NANCY GIEZEN
Regulation Number888.3040
Classification Product Code
HWC  
Date Received09/27/1995
Decision Date 10/31/1995
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
-
-