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#
- 3038776593
- 3004142400
- 3016050940
- 3024856795
- 8010433
- 1450428
- 3005820796
- 3004983210
- 3005677016
- 9617544
- 3011307621
- 3006395932
- 2242056
- 1531174
- 2020550
- 9680718
- 3015895045
- 9611102
- 3001239363
- 9616250
- 1836161
- 9611281
- 3010927122
- 3015869121
- 9611503
- 1221763
- 3010509633
- 3019356409
- 9611813
- 1423662
- 3010009693
- 9613350
- 3023443842
- 3003541440
- 3042765769
- 3004153240
- 3019455
- 3014252644
- 1218882
- 3009882675
- 3007303113
- 3009106092
- 3005004799
- 3003526896
- 3005144609
- 3011513267
- 3009996260
- 2132732
- 3021389253
- 3023194129
- 9611616
- 3009381600
- 9681147
- 9680825
- 3015200759
- 3009504230
- 3012329552
- 3009169996
- 3008627763
- 8043769
- 3016002322
- 1000517406
- 1223656
- 3001415205
- 3013055499
- 3014315669
- 2133687
- 9610621
- 3008668801
- 8010944
- 3005067367
- 9613926
- 3008395366
- 3010123172
- 3007728266
- 3007193505
- 3029933740
- 3011390763
- 2529846
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#
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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