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FDA 510(k)

SMC 28MM CERAMIC FEMORAL HEADS

K-Number: K981302 · 1998-06-25

ApplicantSignal Medical Corp.
Decision Date1998-06-25
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMC 28MM CERAMIC FEMORAL HEADS 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 1998-06-25 under 510(k) number K981302. 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 SMC 28MM CERAMIC FEMORAL HEADS?

SMC 28MM CERAMIC FEMORAL HEADS is a medical device that received FDA 510(k) clearance on 1998-06-25. The listed applicant is Signal Medical Corp.. The 510(k) number is K981302.

When did SMC 28MM CERAMIC FEMORAL HEADS receive FDA 510(k) clearance?

SMC 28MM CERAMIC FEMORAL HEADS received FDA 510(k) clearance on 1998-06-25, under 510(k) number K981302.

Who is the listed applicant for SMC 28MM CERAMIC FEMORAL HEADS?

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 28MM CERAMIC FEMORAL HEADS?

The FDA product code for SMC 28MM CERAMIC FEMORAL HEADS is LZO.

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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: 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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