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FDA 510(k)

Fine Osteotomy™

K-Number: K250923 · 2025-08-21

ApplicantBodycad Laboratories, Inc.
Decision Date2025-08-21
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 2025-08-21 under 510(k) number K250923. 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 2025-08-21. The listed applicant is Bodycad Laboratories, Inc.. The 510(k) number is K250923.

When did Fine Osteotomy™ receive FDA 510(k) clearance?

Fine Osteotomy™ received FDA 510(k) clearance on 2025-08-21, under 510(k) number K250923.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253300Fine Osteotomy™K250394Fine TTO™K241356Fine Osteotomy™K240703Fine Osteotomy™K240066Fine Osteotomy™K231314Fine Osteotomy™

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Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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