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FDA 510(k)

G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)

K-Number: K982812 · 1998-12-04

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1998-12-04
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Professionals, Inc.. It received FDA 510(k) clearance on 1998-12-04 under 510(k) number K982812. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)?

G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) is a medical device that received FDA 510(k) clearance on 1998-12-04. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K982812.

When did G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) receive FDA 510(k) clearance?

G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) received FDA 510(k) clearance on 1998-12-04, under 510(k) number K982812.

Who is the listed applicant for G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)?

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

What is the FDA product code for G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)?

The FDA product code for G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) is KWY.

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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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