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)

APEX KNEE MODULAR TIBIA SYSTEM

K-Number: K101994 · 2010-09-28

ApplicantOmnlife Science
Decision Date2010-09-28
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APEX KNEE MODULAR TIBIA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Omnlife Science. It received FDA 510(k) clearance on 2010-09-28 under 510(k) number K101994. 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 APEX KNEE MODULAR TIBIA SYSTEM?

APEX KNEE MODULAR TIBIA SYSTEM is a medical device that received FDA 510(k) clearance on 2010-09-28. The listed applicant is Omnlife Science. The 510(k) number is K101994.

When did APEX KNEE MODULAR TIBIA SYSTEM receive FDA 510(k) clearance?

APEX KNEE MODULAR TIBIA SYSTEM received FDA 510(k) clearance on 2010-09-28, under 510(k) number K101994.

Who is the listed applicant for APEX KNEE MODULAR TIBIA SYSTEM?

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

What is the FDA product code for APEX KNEE MODULAR TIBIA SYSTEM?

The FDA product code for APEX KNEE MODULAR TIBIA SYSTEM 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 Omnlife Science 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.

K112779APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM)K101575APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,304010K100151APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM)K073602MODIFICATION TO: APEX KNEE SYSTEM

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.

↑