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 Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K254176
Device Name SINEFIX
Applicant
BAAT Medical Products B.V.
F. Hazemeijerstraat 800
Bldg. A04
Hengelo,  NL 7555RJ
Applicant Contact Jasper Springer
Correspondent
BAAT Medical Products B.V.
F. Hazemeijerstraat 800
Bldg. A04
Hengelo,  NL 7555RJ
Correspondent Contact Jasper Springer
Regulation Number888.3040
Classification Product Code
MBI  
Date Received12/23/2025
Decision Date 03/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-