510(k) K230067
- Device
- Para-Fix External Fixation System
- Applicant
- New Paradigm Biomedical
- 510(k) number
- K230067
- Product code
- LXT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-09-22
- Date received
- 2023-01-09
- Regulation
- 888.3030
- Classification name
- Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- John Wixted
- Address
- 163 Highland Ave. #1144 Needham MA US 02494 02494
FDA Registration Numbers#
- 3015869492
- 9615800
- 2029275
- 3014315669
- 2183449
- 2437731
- 3021008900
- 3033509898
- 3007993775
- 3002907620
- 3003108161
- 1043653
- 3014207283
- 3008868758
- 3014315560
- 1644408
- 2245304
- 9611863
- 3005893246
- 8043792
- 3014680795
- 1526439
- 1220477
- 3005061536
- 3008812560
- 3006783837
- 3003860203
- 3025141
- 3000270450
- 3009417901
- 3015440604
- 1020279
- 3004983210
- 1825034
- 2183946
- 3007539489
- 3013055499
- 1828288
- 2134947
- 3010162973
- 3010158639
- 1526534
- 3025603301
- 3010120104
- 3006742481
- 2031910
- 3009546990
- 3015876273
- 3015207155
- 3006694268
- 1835831
- 3010049501
- 3006946279
- 3004748528
- 1828464
- 3003387384
- 3004049923
- 3006801265
- 1834331
- 1054811
- 3008534770
- 3007738812
- 3008744062
- 1424263
- 3010462278
- 1222773
- 3015212339
- 3013176080
- 3006015326
- 1643264
- 8031020
- 3007923096
- 3035366890
- 3004976965
- 3014302784
- 2032098
- 1833920
- 3036756245
- 3038503932
Source Documents#
Other 510(k) Records For Product Code LXT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K131636 | POLARUS CONNECT | Acumed, LLC | 2013-10-10 |
| K132704 | DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW | Biomet | 2013-10-09 |
| K112345 | DISTAL VOLAR RADIUS PLATING SYSTEMS | Medos International SARL | 2011-10-31 |
| K090374 | STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S | DePuy Orthopaedics, Inc. | 2009-03-11 |
| K073135 | SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS | Synthes (Usa) | 2008-01-29 |
| K063832 | SYNTHES (USA) ELBOW HINGE FIXATOR | Synthes (Usa) | 2007-03-07 |
| K060864 | MULTIDIRECTIONAL THREADED PEG | Hand Innovations, LLC | 2006-04-28 |
| K060403 | PTA (PROGRESSIVE TIBIAL ALIGNMENT) | Meridian Medical | 2006-03-28 |
| K060290 | SHOULDER FIXATION SYSTEM | Hand Innovations, LLC | 2006-02-27 |
| K052754 | WRIST FUSION PLATE | Dvo Extremity Solutions, LLC | 2005-10-27 |
| K051728 | MODIFICATION TO SHOULDER FIXATION SYSTEM | Hand Innovations, LLC | 2005-07-20 |
| K051306 | HOFFMANN II MRI EXTERNAL FIXATION SYSTEM | Howmedica Osteonics Corp. | 2005-06-17 |
| K050932 | DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM | Hand Innovations, Inc. | 2005-04-26 |
| K050631 | SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSION | Synthes (Usa) | 2005-04-11 |
| K042458 | A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM | A.M. Surgical, Inc. | 2004-10-07 |