Regulatory filing

K253661 (us_fda)

FDA 510(k) K253661 for TMINI 1.1 Miniature Robotic System. Multiple implant clearances (MOBIO, Medacta GMK Sphere).

fda 510k · cleared · decided 2025-12-22

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Key facts

Jurisdiction: us_fda
Filing type: fda 510k
Status: cleared
Filing number: K253661
Filing date: 2025-12-22
Decision date: 2025-12-22
Verification posture: verified

Applicant

Covered models (1)

THINK Surgical TMINI

Sources (1)

https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253661.pdf

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Identity

d0baf901-700b-4a67-9fe2-cce2d0fab7fd