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)

TOTAL KNEE KIT

K-Number: K932918 · 1994-09-01

ApplicantBiodynamic Technologies, Inc.
Decision Date1994-09-01
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TOTAL KNEE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biodynamic Technologies, Inc.. It received FDA 510(k) clearance on 1994-09-01 under 510(k) number K932918. The device is classified under product code HWE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOTAL KNEE KIT?

TOTAL KNEE KIT is a medical device that received FDA 510(k) clearance on 1994-09-01. The listed applicant is Biodynamic Technologies, Inc.. The 510(k) number is K932918.

When did TOTAL KNEE KIT receive FDA 510(k) clearance?

TOTAL KNEE KIT received FDA 510(k) clearance on 1994-09-01, under 510(k) number K932918.

Who is the listed applicant for TOTAL KNEE KIT?

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

What is the FDA product code for TOTAL KNEE KIT?

The FDA product code for TOTAL KNEE KIT is HWE.

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 Biodynamic Technologies, 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.

K990436ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEMK990481ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEMK990513ULTIMAX CORTICAL BONE SCREWSK981230ULTIMAX DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEMK980102BTI HUMERAL INTRAMEDULLARY ROD SYSTEMK974756BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS

View all 30 devices →

Related Devices (Code: HWE)

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.

K102743ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRESOrtho Solutions LimitedK063688SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBEThe Anspach Effort, Inc.K050766EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEMZimmer TrabecularK043310SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEMSynthes (Usa)K022744REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSMedical Device ServicesK012694REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSAdven Medical

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.

↑