Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DEPUY SIGMA TIBIAL INSERTS

K-Number: K033272 · 2004-02-05

ApplicantDePuy Orthopaedics, Inc.
Decision Date2004-02-05
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DEPUY SIGMA TIBIAL INSERTS is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2004-02-05 under 510(k) number K033272. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEPUY SIGMA TIBIAL INSERTS?

DEPUY SIGMA TIBIAL INSERTS is a medical device that received FDA 510(k) clearance on 2004-02-05. The listed applicant is DePuy Orthopaedics, Inc.. The 510(k) number is K033272.

When did DEPUY SIGMA TIBIAL INSERTS receive FDA 510(k) clearance?

DEPUY SIGMA TIBIAL INSERTS received FDA 510(k) clearance on 2004-02-05, under 510(k) number K033272.

Who is the listed applicant for DEPUY SIGMA TIBIAL INSERTS?

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

What is the FDA product code for DEPUY SIGMA TIBIAL INSERTS?

The FDA product code for DEPUY SIGMA TIBIAL INSERTS is JWH.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing DePuy Orthopaedics, 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.

K262130ATTUNE Revision Knee SystemK252887DePuy ATTUNE™ Knee SystemK231503CUPTIMIZE™ AdvancedK213839DePuy Corail AMT Hip ProsthesisK210167DELTA XTEND Reverse Shoulder SystemK203167DePuy Corail AMT Hip Prosthesis

View all 206 devices →

Related Devices (Code: JWH)

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.

K262057GMK ExtensionMedacta International SAK260063GSPE SpacerThe General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.

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.

↑