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FDA 510(k)

PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM

K-Number: K930771 · 1994-11-30

ApplicantOrthomet, Inc.
Decision Date1994-11-30
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthomet, Inc.. It received FDA 510(k) clearance on 1994-11-30 under 510(k) number K930771. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM?

PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM is a medical device that received FDA 510(k) clearance on 1994-11-30. The listed applicant is Orthomet, Inc.. The 510(k) number is K930771.

When did PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM receive FDA 510(k) clearance?

PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM received FDA 510(k) clearance on 1994-11-30, under 510(k) number K930771.

Who is the listed applicant for PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM?

The FDA 510(k) record lists Orthomet, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM?

The FDA product code for PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM is JDI.

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Other records listing Orthomet, Inc. 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.

K936310ORTHOMET HMC FEMORAL STEM COMPONENTK945783ORTHOMET TITANIUM HYBRID FEMORAL STEMK943873ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SYK944752ORTHOMET RESURFACING FEMORAL COMPONENTK926334AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSERK931333ORTHOMET ACETABULAR CUP SYSTEM

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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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