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

K200452 is an FDA 510(k) clearance for the Meril-Bonewax. Classified as Wax, Bone (product code MTJ).

Submitted by M/s. Meril Endo Surgery Private Limited. (Chala, Vapi, IN). The FDA issued a Cleared decision on March 27, 2023 after a review of 1127 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all M/s. Meril Endo Surgery Private Limited. devices