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)

PRACTIFIX EXTERNAL FIXATION SYSTEM

K-Number: K960014 · 1996-03-18

ApplicantOrthopaedic Innovations, Inc.
Decision Date1996-03-18
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PRACTIFIX EXTERNAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthopaedic Innovations, Inc.. It received FDA 510(k) clearance on 1996-03-18 under 510(k) number K960014. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRACTIFIX EXTERNAL FIXATION SYSTEM?

PRACTIFIX EXTERNAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 1996-03-18. The listed applicant is Orthopaedic Innovations, Inc.. The 510(k) number is K960014.

When did PRACTIFIX EXTERNAL FIXATION SYSTEM receive FDA 510(k) clearance?

PRACTIFIX EXTERNAL FIXATION SYSTEM received FDA 510(k) clearance on 1996-03-18, under 510(k) number K960014.

Who is the listed applicant for PRACTIFIX EXTERNAL FIXATION SYSTEM?

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

What is the FDA product code for PRACTIFIX EXTERNAL FIXATION SYSTEM?

The FDA product code for PRACTIFIX EXTERNAL FIXATION SYSTEM is KTT.

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 Orthopaedic Innovations, 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.

K020145ORTHOPAEDIC INNOVATIONS RENEWAL ACETABULAR CUP SYSTEMK983881COBRA EXTERNAL FIXATORK962646PRIME MODULAR ENDO HEADK955620PRIME CEMENTED CALCAR FEMORAL STEMSK955751PRIME FEMORAL CEMENT PLUGK953033PRIME CEMENTED SMALL FEMORAL STEM

View all 8 devices →

Related Devices (Code: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253202Hoffmann LRF SystemStryker GmbHK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.

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.

↑