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FDA 510(k)

BICONTACT HIP STEM AND FEMORAL HEAD

K-Number: K040191 · 2004-08-25

ApplicantAesculap
Decision Date2004-08-25
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BICONTACT HIP STEM AND FEMORAL HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap. It received FDA 510(k) clearance on 2004-08-25 under 510(k) number K040191. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BICONTACT HIP STEM AND FEMORAL HEAD?

BICONTACT HIP STEM AND FEMORAL HEAD is a medical device that received FDA 510(k) clearance on 2004-08-25. The listed applicant is Aesculap. The 510(k) number is K040191.

When did BICONTACT HIP STEM AND FEMORAL HEAD receive FDA 510(k) clearance?

BICONTACT HIP STEM AND FEMORAL HEAD received FDA 510(k) clearance on 2004-08-25, under 510(k) number K040191.

Who is the listed applicant for BICONTACT HIP STEM AND FEMORAL HEAD?

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

What is the FDA product code for BICONTACT HIP STEM AND FEMORAL HEAD?

The FDA product code for BICONTACT HIP STEM AND FEMORAL HEAD is LPH.

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Other records listing Aesculap 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.

K093649AESCULAP STERILCONTAINER SK062085S4 SPINAL SYSTEMK062510AESCULAP STERILCONTAINER SYSTEMK061135MINOP DISPOSABLE INTRODUCER 10F, MODEL ME010; 19F, MODEL ME019K043079BICONTACT HIP SYSTEM WITH U-CAPK040865AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER

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Related Devices (Code: LPH)

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.

K261453G7® Acetabular SystemZimmer BiometK253630Mpact 3D Metal FoamMedacta International S.A.K254043TRIVANCE™ Hip StemGlobus Medical, Inc.K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLCK251270Taperloc® Complete Hip StemBiomet, 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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