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)

P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5)

K-Number: K961685 · 1996-07-10

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1996-07-10
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5) is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Professionals, Inc.. It received FDA 510(k) clearance on 1996-07-10 under 510(k) number K961685. 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 P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5)?

P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5) is a medical device that received FDA 510(k) clearance on 1996-07-10. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K961685.

When did P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5) receive FDA 510(k) clearance?

P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5) received FDA 510(k) clearance on 1996-07-10, under 510(k) number K961685.

Who is the listed applicant for P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5)?

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

What is the FDA product code for P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5)?

The FDA product code for P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5) 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 Johnson & Johnson Professionals, 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.

K992173SIPHONGUARD CSF CONTROL DEVICEK991413CODMAN ETHISORB DURA PATCHK991222CODMAN MICROSENSOR VENTRICULAR CATHETER KITK982379SUNDT SLIM-LINE ANEURYSM CLIP APPLIERK982812G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)K983141CAPITELLO-CONDYLAR TOTAL ELBOW 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.

↑