Last synced on 18 April 2025 at 11:05 pm

SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K111399
510(k) Type
Special
Applicant
ARTHROCARE CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/20/2011
Days to Decision
62 days
Submission Type
Summary

SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K111399
510(k) Type
Special
Applicant
ARTHROCARE CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/20/2011
Days to Decision
62 days
Submission Type
Summary