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FDA 510(k)

HAND REAMERS

K-Number: K770203 · 1977-02-08

ApplicantDepuy, Inc.
Decision Date1977-02-08
Product CodeHTO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HAND REAMERS is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1977-02-08 under 510(k) number K770203. The device is classified under product code HTO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HAND REAMERS?

HAND REAMERS is a medical device that received FDA 510(k) clearance on 1977-02-08. The listed applicant is Depuy, Inc.. The 510(k) number is K770203.

When did HAND REAMERS receive FDA 510(k) clearance?

HAND REAMERS received FDA 510(k) clearance on 1977-02-08, under 510(k) number K770203.

Who is the listed applicant for HAND REAMERS?

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

What is the FDA product code for HAND REAMERS?

The FDA product code for HAND REAMERS is HTO.

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Other records listing Depuy, 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.

K043058PINNACLE CONSTRAINED ACETABULAR LINERSK042664LPS UPPER EXTREMITYK041085LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARYK033959LPSK040544DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062K021478DELTA SHOULDER

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Related Devices (Code: HTO)

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.

K111437SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)Synthes (USA) Products, LLCK042899SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONSSynthes (Usa)K013527MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEMSynthes (Usa)K993335SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEMSynthes (Usa)K954915FLEXIBLE INTRAMEDULLARY REAMERZimmer, Inc.K903248COMBINATION REAMEROnyx Medical Corp.

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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