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FDA 510(k)

BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1

K-Number: K012702 · 2002-01-30

ApplicantEndotec, Inc.
Decision Date2002-01-30
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1 is the device name listed in this FDA 510(k) record. The listed applicant is Endotec, Inc.. It received FDA 510(k) clearance on 2002-01-30 under 510(k) number K012702. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1?

BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1 is a medical device that received FDA 510(k) clearance on 2002-01-30. The listed applicant is Endotec, Inc.. The 510(k) number is K012702.

When did BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1 receive FDA 510(k) clearance?

BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1 received FDA 510(k) clearance on 2002-01-30, under 510(k) number K012702.

Who is the listed applicant for BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1?

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

What is the FDA product code for BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1?

The FDA product code for BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1 is JWH.

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Related Devices (Code: JWH)

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.

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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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