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)

PRIMALOC CEMENTED HIP SYSTEM

K-Number: K962448 · 1996-09-19

ApplicantOrtho Development Corp.
Decision Date1996-09-19
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

PRIMALOC CEMENTED HIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Development Corp.. It received FDA 510(k) clearance on 1996-09-19 under 510(k) number K962448. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the PRIMALOC CEMENTED HIP SYSTEM?

PRIMALOC CEMENTED HIP SYSTEM is a medical device that received FDA 510(k) clearance on 1996-09-19. The listed applicant is Ortho Development Corp.. The 510(k) number is K962448.

When did PRIMALOC CEMENTED HIP SYSTEM receive FDA 510(k) clearance?

PRIMALOC CEMENTED HIP SYSTEM received FDA 510(k) clearance on 1996-09-19, under 510(k) number K962448.

Who is the listed applicant for PRIMALOC CEMENTED HIP SYSTEM?

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

What is the FDA product code for PRIMALOC CEMENTED HIP SYSTEM?

The FDA product code for PRIMALOC CEMENTED HIP SYSTEM is KWY.

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 Ortho Development 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.

K253161Balanced Knee System TriMax Porous Femoral ComponentsK251052Trivicta® Hip StemK242984BKS Revision SystemK242833Legend® Acetabular ShellK233758Trivicta™ Hip StemK131022OVATION 10/12 HIP STEM

View all 41 devices →

Related Devices (Code: KWY)

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.

K253357b-ONE® Bipolar HeadB-One Ortho, Corp.K243634Maxx Libertas Bipolar Hip Head (Bipolar Hip)Maxx Orthopedics, Inc.K231526CORAIL Cemented Femoral StemDepuy Ireland UCK223441SpaceFlex Acetabular CupG21, S.R.L.K221794Vario-Cup SystemWaldemar Link GmbH & Co. KGK220492COPAL exchange G hip spacerHeraeus Medical GmbH

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.

↑