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#
- 3002808022
- 9615004
- 3037407500
- 9681258
- 3013557562
- 1724955
- 3011061242
- 3010041430
- 3006846753
- 1057425
- 3020665200
- 8031020
- 3009971621
- 3015539532
- 3042278955
- 3042989733
- 3006946279
- 3005536892
- 3009822485
- 3012429289
- 3016002322
- 3014725904
- 8010665
- 3018080016
- 3013820441
- 3015440604
- 1032347
- 1030489
- 3002976036
- 3007014520
- 3004112448
- 8010235
- 3008274656
- 3012119238
- 1835251
- 1834331
- 9611281
- 2249418
- 1223651
- 3004638532
- 9615013
- 1417485
- 3008215723
- 1043534
- 3005827567
- 3015869121
- 3010141347
- 1000606483
- 8010300
- 2183946
- 3010536692
- 9612278
- 3004370612
- 3009628349
- 2950160
- 9617297
- 3011530718
- 3015231789
- 8010591
- 3007766601
- 1835444
- 3009189869
- 3009746061
- 3010760216
- 1000461041
- 3005706667
- 2132732
- 1000422168
- 3015176311
- 1720747
- 2433012
- 3002498892
- 3003249380
- 3023443842
- 3009882462
- 3011274144
- 3010763958
- 2184171
- 2030380
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