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FDA 510(k)

SMC FEMORAL HIP COMPONENT

K-Number: K971681 · 1997-12-04

ApplicantSignal Medical Corp.
Decision Date1997-12-04
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMC FEMORAL HIP COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Signal Medical Corp.. It received FDA 510(k) clearance on 1997-12-04 under 510(k) number K971681. 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 SMC FEMORAL HIP COMPONENT?

SMC FEMORAL HIP COMPONENT is a medical device that received FDA 510(k) clearance on 1997-12-04. The listed applicant is Signal Medical Corp.. The 510(k) number is K971681.

When did SMC FEMORAL HIP COMPONENT receive FDA 510(k) clearance?

SMC FEMORAL HIP COMPONENT received FDA 510(k) clearance on 1997-12-04, under 510(k) number K971681.

Who is the listed applicant for SMC FEMORAL HIP COMPONENT?

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

What is the FDA product code for SMC FEMORAL HIP COMPONENT?

The FDA product code for SMC FEMORAL HIP COMPONENT is JDI.

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Other records listing Signal Medical Corp. 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.

K100370SYMMETRIC TOTAL KNEE AGUMENTSK073674BONE FIXATION WIRE (KIRSCHNER WIRE)K051510SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEMK043289E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOTK022382RHS ACETABULAR COMPONENTK021063GREAT TOE IMPLANT

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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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