Regulatory filing

K072806 (us_fda)

Foundational FDA 510(k) clearance of the MAKO Tactile Guidance System (TGS), the robotic-arm orthopedic platform underpinning Mako/RIO; filed by MAKO Surgical Corp. (acquired by Stryker in 2013).

fda 510k · cleared · decided 2008-01-24

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Revision history: /regulatory-filings/fda-510k-mako-tgs-2008/history
Data documentation: /data
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Key facts

Jurisdiction: us_fda
Filing type: fda 510k
Status: cleared
Filing number: K072806
Filing date: 2007-10-01
Decision date: 2008-01-24
Verification posture: verified

Applicant

Stryker

Covered models (1)

Mako

Sources (1)

https://api.fda.gov/device/510k.json?search=k_number:K072806

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Identity

1ad00c66-3361-4d19-b0c7-0dba0d40f06f