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PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K083565
510(k) Type
Special
Applicant
SMITH & NEPHEW, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/20/2009
Days to Decision
79 days
Submission Type
Summary

PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K083565
510(k) Type
Special
Applicant
SMITH & NEPHEW, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/20/2009
Days to Decision
79 days
Submission Type
Summary