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FDA 510(k)

CLS STEM (MODIFICATION)

K-Number: K953690 · 1996-06-07

ApplicantIntermedics Orthopedics
Decision Date1996-06-07
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CLS STEM (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics Orthopedics. It received FDA 510(k) clearance on 1996-06-07 under 510(k) number K953690. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLS STEM (MODIFICATION)?

CLS STEM (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1996-06-07. The listed applicant is Intermedics Orthopedics. The 510(k) number is K953690.

When did CLS STEM (MODIFICATION) receive FDA 510(k) clearance?

CLS STEM (MODIFICATION) received FDA 510(k) clearance on 1996-06-07, under 510(k) number K953690.

Who is the listed applicant for CLS STEM (MODIFICATION)?

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 CLS STEM (MODIFICATION)?

The FDA product code for CLS STEM (MODIFICATION) 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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