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FDA 510(k)

BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT

K-Number: K992394 · 1999-10-15

ApplicantEndotec, Inc.
Decision Date1999-10-15
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Endotec, Inc.. It received FDA 510(k) clearance on 1999-10-15 under 510(k) number K992394. The device is classified under product code HSD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT?

BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT is a medical device that received FDA 510(k) clearance on 1999-10-15. The listed applicant is Endotec, Inc.. The 510(k) number is K992394.

When did BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT receive FDA 510(k) clearance?

BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT received FDA 510(k) clearance on 1999-10-15, under 510(k) number K992394.

Who is the listed applicant for BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT?

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 HUMERAL HEAD RESURFACING COMPONENT?

The FDA product code for BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT is HSD.

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Other records listing Endotec, 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.

K081400FANNING-PAPPAS MODULAR KNEE BEARINGK012702BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1K982418BUECHEL-PAPPAS MODULAR SALVAGE STEMK963101B-P HEMISPHERICAL ACETABULAR COMPONENTK963100TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUPK960425BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX

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Related Devices (Code: HSD)

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.

K233260Univers Revers CA Head and AdapterArthrex, Inc.K221232Univers Revers Humeral Cup ImplantArthrex, Inc.K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbHK193122Biocore9 Humeral Resurfacing SystemBiocore9, LLCK173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc.K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, 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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