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FDA 510(k)

ABC-1000 SMALL JOINT REAMERS

K-Number: K862933 · 1986-08-18

ApplicantInstrumentation Industries, Inc.
Decision Date1986-08-18
Product CodeHTO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ABC-1000 SMALL JOINT REAMERS is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Industries, Inc.. It received FDA 510(k) clearance on 1986-08-18 under 510(k) number K862933. 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 ABC-1000 SMALL JOINT REAMERS?

ABC-1000 SMALL JOINT REAMERS is a medical device that received FDA 510(k) clearance on 1986-08-18. The listed applicant is Instrumentation Industries, Inc.. The 510(k) number is K862933.

When did ABC-1000 SMALL JOINT REAMERS receive FDA 510(k) clearance?

ABC-1000 SMALL JOINT REAMERS received FDA 510(k) clearance on 1986-08-18, under 510(k) number K862933.

Who is the listed applicant for ABC-1000 SMALL JOINT REAMERS?

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

What is the FDA product code for ABC-1000 SMALL JOINT REAMERS?

The FDA product code for ABC-1000 SMALL JOINT REAMERS is HTO.

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Other records listing Instrumentation Industries, Inc. as applicant

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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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