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FDA 510(k)

WARSAW ORTHOPEDIC POINTED REAMER

K-Number: K870845 · 1987-03-11

ApplicantWarsaw Orthopedic, Inc.
Decision Date1987-03-11
Product CodeHTO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

WARSAW ORTHOPEDIC POINTED REAMER is the device name listed in this FDA 510(k) record. The listed applicant is Warsaw Orthopedic, Inc.. It received FDA 510(k) clearance on 1987-03-11 under 510(k) number K870845. 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 WARSAW ORTHOPEDIC POINTED REAMER?

WARSAW ORTHOPEDIC POINTED REAMER is a medical device that received FDA 510(k) clearance on 1987-03-11. The listed applicant is Warsaw Orthopedic, Inc.. The 510(k) number is K870845.

When did WARSAW ORTHOPEDIC POINTED REAMER receive FDA 510(k) clearance?

WARSAW ORTHOPEDIC POINTED REAMER received FDA 510(k) clearance on 1987-03-11, under 510(k) number K870845.

Who is the listed applicant for WARSAW ORTHOPEDIC POINTED REAMER?

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

What is the FDA product code for WARSAW ORTHOPEDIC POINTED REAMER?

The FDA product code for WARSAW ORTHOPEDIC POINTED REAMER is HTO.

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Other records listing Warsaw Orthopedic, 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.

K892877CRADLE, HOSPITAL BED CLOTHINGK883784TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATEK883783TSRH SACRAL SPINAL SCREWK880211TSRH H/M HOOK HOLDERK880212TSRH H/M HOOK HOLDER W/ROD MOVERK880215TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD

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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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