Cleared Traditional

K200452 - Meril-Bonewax (FDA 510(k) Clearance)

K200452 · M/s. Meril Endo Surgery Private Limited. · Orthopedic device

Mar 2023

Decision

1127d

Days

Risk

K200452 is an FDA 510(k) clearance for the Meril-Bonewax. This device is classified as a Wax, Bone.

Submitted by M/s. Meril Endo Surgery Private Limited. (Chala, Vapi, IN). The FDA issued a Cleared decision on March 27, 2023, 1127 days after receiving the submission on February 24, 2020.

This device falls under the Orthopedic FDA review panel.

Submission Details

510(k) Number	K200452 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 24, 2020
Decision Date	March 27, 2023
Days to Decision	1127 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF