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FDA 510(k)

REESE OSTEOTOMY GUIDE SYS

K-Number: K841470 · 1984-05-23

ApplicantOsteotomy Guide Co.
Decision Date1984-05-23
Product CodeHTH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REESE OSTEOTOMY GUIDE SYS is the device name listed in this FDA 510(k) record. The listed applicant is Osteotomy Guide Co.. It received FDA 510(k) clearance on 1984-05-23 under 510(k) number K841470. The device is classified under product code HTH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REESE OSTEOTOMY GUIDE SYS?

REESE OSTEOTOMY GUIDE SYS is a medical device that received FDA 510(k) clearance on 1984-05-23. The listed applicant is Osteotomy Guide Co.. The 510(k) number is K841470.

When did REESE OSTEOTOMY GUIDE SYS receive FDA 510(k) clearance?

REESE OSTEOTOMY GUIDE SYS received FDA 510(k) clearance on 1984-05-23, under 510(k) number K841470.

Who is the listed applicant for REESE OSTEOTOMY GUIDE SYS?

The FDA 510(k) record lists Osteotomy Guide Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REESE OSTEOTOMY GUIDE SYS?

The FDA product code for REESE OSTEOTOMY GUIDE SYS is HTH.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Osteotomy Guide Co. 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.

K861576SHORTENING OSTEOTOMY GUIDEK860323REESE ARTHRODESIS SCREW

Related Devices (Code: HTH)

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.

K861576SHORTENING OSTEOTOMY GUIDEOsteotomy Guide Co.K822305ORTHO-LEVELFrontier Products

Official Source

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

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