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SPAR-K Instruments (for use with Gemini SL Total Knee System)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191755
510(k) Type
Special
Applicant
Waldemar Link GmbH & Co. KG
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
7/18/2019
Days to Decision
17 days
Submission Type
Summary

SPAR-K Instruments (for use with Gemini SL Total Knee System)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191755
510(k) Type
Special
Applicant
Waldemar Link GmbH & Co. KG
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
7/18/2019
Days to Decision
17 days
Submission Type
Summary