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FDA 510(k)

FINE Osteotomy

K-Number: K211646 · 2021-07-28

ApplicantBodycad Laboratories, Inc.
Decision Date2021-07-28
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FINE Osteotomy is the device name listed in this FDA 510(k) record. The listed applicant is Bodycad Laboratories, Inc.. It received FDA 510(k) clearance on 2021-07-28 under 510(k) number K211646. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FINE Osteotomy?

FINE Osteotomy is a medical device that received FDA 510(k) clearance on 2021-07-28. The listed applicant is Bodycad Laboratories, Inc.. The 510(k) number is K211646.

When did FINE Osteotomy receive FDA 510(k) clearance?

FINE Osteotomy received FDA 510(k) clearance on 2021-07-28, under 510(k) number K211646.

Who is the listed applicant for FINE Osteotomy?

The FDA 510(k) record lists Bodycad Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FINE Osteotomy?

The FDA product code for FINE Osteotomy is HRS.

Other records listing Bodycad Laboratories, Inc. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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