EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM— 510(k) K962846
Substantially EquivalentBiodynamic Technologies, Inc.
FDA 510(k) clearance K962846 for EZ-FIX COMPRESSION HIP/SUPRACONDYLAR SCREW (CHS) SYSTEM, Substantially Equivalent on 1996-10-23. Applicant: Biodynamic Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Biodynamic Technologies, Inc.
- Product code
- Code LXT
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Deerfield Beach, FL, US
Recent devices under product code LXT
view all- K230067 — Para-Fix External Fixation System
- K131636 — POLARUS CONNECT
- K132704 — DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW
- K112345 — DISTAL VOLAR RADIUS PLATING SYSTEMS
- K090374 — STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S
More clearances from Biodynamic Technologies, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.