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FDA 510(k)

CONSENSUS(TM) PATELLA REAMER

K-Number: K946197 · 1995-04-05

ApplicantU.S. Medical Products, Inc.
Decision Date1995-04-05
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CONSENSUS(TM) PATELLA REAMER is the device name listed in this FDA 510(k) record. The listed applicant is U.S. Medical Products, Inc.. It received FDA 510(k) clearance on 1995-04-05 under 510(k) number K946197. The device is classified under product code HWE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONSENSUS(TM) PATELLA REAMER?

CONSENSUS(TM) PATELLA REAMER is a medical device that received FDA 510(k) clearance on 1995-04-05. The listed applicant is U.S. Medical Products, Inc.. The 510(k) number is K946197.

When did CONSENSUS(TM) PATELLA REAMER receive FDA 510(k) clearance?

CONSENSUS(TM) PATELLA REAMER received FDA 510(k) clearance on 1995-04-05, under 510(k) number K946197.

Who is the listed applicant for CONSENSUS(TM) PATELLA REAMER?

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

What is the FDA product code for CONSENSUS(TM) PATELLA REAMER?

The FDA product code for CONSENSUS(TM) PATELLA REAMER is HWE.

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Other records listing U.S. Medical Products, 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.

K962215CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTERK954818CONSENSUS POSTERIOR STABILIZED KNEEK953443CONSENSUS PCL SUBSITUTING TIBIAL INSERTK960302CONSENSUS ACETABULAR SHELL, ALL UHMWPEK952943CONSENSUS ALL POLY TIBIAK960340CONSENSUS APEX DOME HOLE PLUG

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Related Devices (Code: HWE)

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.

K102743ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRESOrtho Solutions LimitedK063688SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBEThe Anspach Effort, Inc.K050766EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEMZimmer TrabecularK043310SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEMSynthes (Usa)K022744REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSMedical Device ServicesK012694REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSAdven Medical

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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