Last synced on 18 April 2025 at 11:05 pm

SIMPACT IMPLANT SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K081226
510(k) Type
Traditional
Applicant
SIMPACT LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/12/2008
Days to Decision
135 days
Submission Type
Summary

SIMPACT IMPLANT SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K081226
510(k) Type
Traditional
Applicant
SIMPACT LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/12/2008
Days to Decision
135 days
Submission Type
Summary