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FDA 510(k)

OPTION SHELL

K-Number: K942406 · 1994-10-05

ApplicantIntermedics Orthopedics
Decision Date1994-10-05
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OPTION SHELL is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics Orthopedics. It received FDA 510(k) clearance on 1994-10-05 under 510(k) number K942406. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTION SHELL?

OPTION SHELL is a medical device that received FDA 510(k) clearance on 1994-10-05. The listed applicant is Intermedics Orthopedics. The 510(k) number is K942406.

When did OPTION SHELL receive FDA 510(k) clearance?

OPTION SHELL received FDA 510(k) clearance on 1994-10-05, under 510(k) number K942406.

Who is the listed applicant for OPTION SHELL?

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 OPTION SHELL?

The FDA product code for OPTION SHELL is JDI.

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Other records listing Intermedics Orthopedics as applicant

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Related Devices (Code: JDI)

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.

K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer BiometK240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics

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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