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)

S-ROM NOILES POSTERIOR STABILIZED TOTAL KNEE SYSTEM II

K-Number: K944321 · 1995-08-14

ApplicantJoint Medical Products Corp.
Decision Date1995-08-14
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

S-ROM NOILES POSTERIOR STABILIZED TOTAL KNEE SYSTEM II is the device name listed in this FDA 510(k) record. The listed applicant is Joint Medical Products Corp.. It received FDA 510(k) clearance on 1995-08-14 under 510(k) number K944321. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the S-ROM NOILES POSTERIOR STABILIZED TOTAL KNEE SYSTEM II?

S-ROM NOILES POSTERIOR STABILIZED TOTAL KNEE SYSTEM II is a medical device that received FDA 510(k) clearance on 1995-08-14. The listed applicant is Joint Medical Products Corp.. The 510(k) number is K944321.

When did S-ROM NOILES POSTERIOR STABILIZED TOTAL KNEE SYSTEM II receive FDA 510(k) clearance?

S-ROM NOILES POSTERIOR STABILIZED TOTAL KNEE SYSTEM II received FDA 510(k) clearance on 1995-08-14, under 510(k) number K944321.

Who is the listed applicant for S-ROM NOILES POSTERIOR STABILIZED TOTAL KNEE SYSTEM II?

The FDA 510(k) record lists Joint Medical Products Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S-ROM NOILES POSTERIOR STABILIZED TOTAL KNEE SYSTEM II?

The FDA product code for S-ROM NOILES POSTERIOR STABILIZED TOTAL KNEE SYSTEM II 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 Joint Medical Products Corp. 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.

K955511ARTHOPOR I & II ACETABULAR CUP/ARTHOPOR II OBLONG ACETABULAR CUPK954935S-ROM FEMORAL HIP STEM - SIZE 14 X 8K951726S-ROM ZTP UHMWPE ACETABULAR CUPK951084S-ROM OPC (ONE-PIECE CEMENTED) II FEMORAL HIP PROSTHESISK951000ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP SYSTEMK941769KNEE PROTHESIS

View all 33 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.

↑