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FDA 510(k)

PERFECTA TOTAL HIP SYSTEM AND PROFORMA TOTAL HIP

K-Number: K922733 · 1993-02-09

ApplicantOrthomet, Inc.
Decision Date1993-02-09
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PERFECTA TOTAL HIP SYSTEM AND PROFORMA TOTAL HIP is the device name listed in this FDA 510(k) record. The listed applicant is Orthomet, Inc.. It received FDA 510(k) clearance on 1993-02-09 under 510(k) number K922733. 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 PERFECTA TOTAL HIP SYSTEM AND PROFORMA TOTAL HIP?

PERFECTA TOTAL HIP SYSTEM AND PROFORMA TOTAL HIP is a medical device that received FDA 510(k) clearance on 1993-02-09. The listed applicant is Orthomet, Inc.. The 510(k) number is K922733.

When did PERFECTA TOTAL HIP SYSTEM AND PROFORMA TOTAL HIP receive FDA 510(k) clearance?

PERFECTA TOTAL HIP SYSTEM AND PROFORMA TOTAL HIP received FDA 510(k) clearance on 1993-02-09, under 510(k) number K922733.

Who is the listed applicant for PERFECTA TOTAL HIP SYSTEM AND PROFORMA TOTAL HIP?

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 AND PROFORMA TOTAL HIP?

The FDA product code for PERFECTA TOTAL HIP SYSTEM AND PROFORMA TOTAL HIP 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 COMPONENTK930771PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEMK926334AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER

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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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