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FDA 510(k)

BDH UNIVERSAL HIP SYSTEM SURGEON

K-Number: K833468 · 1983-12-27

ApplicantCarbomedics, Inc.
Decision Date1983-12-27
Product CodeJDG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BDH UNIVERSAL HIP SYSTEM SURGEON is the device name listed in this FDA 510(k) record. The listed applicant is Carbomedics, Inc.. It received FDA 510(k) clearance on 1983-12-27 under 510(k) number K833468. The device is classified under product code JDG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BDH UNIVERSAL HIP SYSTEM SURGEON?

BDH UNIVERSAL HIP SYSTEM SURGEON is a medical device that received FDA 510(k) clearance on 1983-12-27. The listed applicant is Carbomedics, Inc.. The 510(k) number is K833468.

When did BDH UNIVERSAL HIP SYSTEM SURGEON receive FDA 510(k) clearance?

BDH UNIVERSAL HIP SYSTEM SURGEON received FDA 510(k) clearance on 1983-12-27, under 510(k) number K833468.

Who is the listed applicant for BDH UNIVERSAL HIP SYSTEM SURGEON?

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

What is the FDA product code for BDH UNIVERSAL HIP SYSTEM SURGEON?

The FDA product code for BDH UNIVERSAL HIP SYSTEM SURGEON is JDG.

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Other records listing Carbomedics, Inc. as applicant

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K970375ANNULOFLO SYSTEMK964665VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)K962154CARBOMEDICS HANDLEK960923CARBOMEDICS MITRAL ROTATORK960706VASCUTEK VASCUSOFT PLUS VASCULAR GRAFTK960169CARBOMEDICS VALVE TESTER

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Related Devices (Code: JDG)

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.

K212431Biomet Answer/Impact/Integral Distal Centralizer/Centering SleeveBiomet, Inc.K193546Distal CentralizersBiomet, Inc.K173499Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsStryker OrthopaedicsK001984PROGENY FORGED COCR CEMENTED FEMORAL COMPONENTStelkast CompanyK992234THE TAPER-FIT TOTAL HIP SYSTEMCorin USAK962002AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEMExactech, Inc.

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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