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FDA 510(k)

MODULAR ACETABULAR SHELL II

K-Number: K955739 · 1996-03-27

ApplicantIntermedics Orthopedics
Decision Date1996-03-27
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODULAR ACETABULAR SHELL II is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics Orthopedics. It received FDA 510(k) clearance on 1996-03-27 under 510(k) number K955739. 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 MODULAR ACETABULAR SHELL II?

MODULAR ACETABULAR SHELL II is a medical device that received FDA 510(k) clearance on 1996-03-27. The listed applicant is Intermedics Orthopedics. The 510(k) number is K955739.

When did MODULAR ACETABULAR SHELL II receive FDA 510(k) clearance?

MODULAR ACETABULAR SHELL II received FDA 510(k) clearance on 1996-03-27, under 510(k) number K955739.

Who is the listed applicant for MODULAR ACETABULAR SHELL II?

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

What is the FDA product code for MODULAR ACETABULAR SHELL II?

The FDA product code for MODULAR ACETABULAR SHELL II is LPH.

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Other records listing Intermedics Orthopedics as applicant

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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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