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FDA 510(k)

NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEMENT STEM

K-Number: K945516 · 1995-02-14

ApplicantIntermedics Orthopedics
Decision Date1995-02-14
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEMENT STEM is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics Orthopedics. It received FDA 510(k) clearance on 1995-02-14 under 510(k) number K945516. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEMENT STEM?

NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEMENT STEM is a medical device that received FDA 510(k) clearance on 1995-02-14. The listed applicant is Intermedics Orthopedics. The 510(k) number is K945516.

When did NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEMENT STEM receive FDA 510(k) clearance?

NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEMENT STEM received FDA 510(k) clearance on 1995-02-14, under 510(k) number K945516.

Who is the listed applicant for NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEMENT STEM?

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 NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEMENT STEM?

The FDA product code for NATURAL-HIP(TM) SYSTEM - CALCAR REPLCEMENT STEM is LZO.

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Other records listing Intermedics Orthopedics 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.

K970300NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTIK970498NATURAL-KNEE II REVISION FEMORAL SPACER LUGSK970166NATURAL-HIP SYSTEM COCR REVISION STEMK970567SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDSK964357NATURAL-HIP SYSTEM COCR STEMK964350MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA

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Related Devices (Code: LZO)

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.

K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.K253948Momentum Acetabular Cup SystemUnited Orthopedic CorporationK261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbH

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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