510(k) K901511
- Device
- CHISEL, BONE, SURGICAL
- Applicant
- MUMTAZ I. MALIK
- 510(k) number
- K901511
- Product code
- LXM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-09-28
- Date received
- 1990-03-29
- Regulation
- 510(k) Premarket Notification
- Classification name
- Manipulator, Plunger-like Joint
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Physical Medicine
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MALIK, M.D.
- Address
- Helm House 100 Diecks Dr. Elizabethtown KY US 42701 42701
FDA Registration Numbers#
- 1935627
- 3006788678
- 1223656
- 3010932096
- 3007728266
- 9710524
- 3018405359
- 3009468807
- 3007038972
- 3001110146
- 3014967149
- 8010769
- 3010836725
- 3003236702
- 3017565094
- 3008840738
- 8010168
- 3008812560
- 8040233
- 3004049923
- 3012086398
- 3014003062
- 3042226236
- 1827813
- 8010591
- 1043534
- 8010422
- 9681191
- 1043572
- 3010331645
- 3016032497
- 3014556807
- 3007993775
- 3015225571
- 3027339877
- 2031910
- 8010250
- 3009882462
- 3006801265
- 3007773213
- 9680619
- 3011274144
- 3015259876
- 3004112448
- 3003898228
- 1417485
- 3005739886
- 3001614464
- 3010362364
- 3019269298
- 3004024955
- 3012507533
- 3011543740
- 3010509633
- 3010365473
- 2320767
- 1644312
- 3014262693
- 1835572
- 3013700547
- 3038776593
- 3012724179
- 3006108336
- 3005180920
- 3003435550
- 3004944585
- 1218882
- 8010935
- 3027660678
- 2320762
- 3016438694
- 3029731364
- 1424434
- 3011410128
- 3015941638
- 3010045785
- 3012764194
- 3036795921
- 1056350
- 9680515
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LXM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K234036 | SONIK MONARK 100 | Neuro Spinal Innovation, Inc. | 2024-02-15 |
| K192629 | Spinalytics | Optima Health Solutions International Corp. | 2019-12-21 |
| K172536 | Atlas Percussion Adjusting Instrument | Spinalight, Inc. | 2018-06-20 |
| K160278 | VSTAAR AdjusteR | Spinal Acoustics, LLC | 2016-11-04 |
| K130666 | KHAN KINETIC TREATMENT (KKT-M2) | Optima Health Solutions International Corporation | 2014-01-23 |
| K112606 | ACTIVATOR V-E | Activator Methods International, Ltd. | 2012-03-06 |
| K082218 | MAX ADJUSTING INSTRUMENT | Manna Omni International, Inc. | 2008-08-13 |
| K080261 | IMPULSE IQ ADJUSTING INSTRUMENT | Neuromechanical Innovations, LLC | 2008-04-11 |
| K072519 | ACTIVATOR V SPINAL ADJUSTING INSTRUMENT | Activator Methods International, Ltd. | 2007-10-23 |
| K060043 | KHAN KINETIC TREATMENT DEVICE (KKT-M1) | Optima Health Solutions International, Inc. | 2006-03-23 |
| K050428 | TECHNOLOGY-ASSISTED MICRO-MOBILIZATION AND REFLEX STIMULATOR (TAMARS) | Advanced Spinal Technologies, Inc. | 2005-06-14 |
| K023462 | IMPULSE-ADJUSTING INSTRUMENT, CBP ADJUSTING INSTRUMENT, NEUROMECHANICAL ADJUSTING INSTRUMENT, MODELS 2003 | Neuromechanical Innovations, LLC | 2003-01-13 |
| K021238 | FRYE ADJUSTING INSTRUMENT | Frye Health Systems | 2002-10-09 |
| K010851 | HARRISON HAND HELD ADJUSTING INSTRUMENT | Harrison Cbp Seminars | 2001-09-18 |
| K003185 | FS ACTIVATOR III | Activator Methods International, Ltd. | 2001-03-20 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases