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#
- 3007700286
- 3016099036
- 3009760038
- 3026576110
- 2320762
- 3004638600
- 3008534770
- 3009546990
- 3013130417
- 9614209
- 8010386
- 3006846753
- 3015991317
- 3008572101
- 3013820441
- 3011189525
- 3017936978
- 3003935342
- 3008627763
- 3006395932
- 3004176895
- 3004112448
- 3011580264
- 8010099
- 2921578
- 8010422
- 3005810686
- 3014257776
- 3004893332
- 3009732568
- 3016239343
- 3018033084
- 3010052529
- 3030966822
- 1000606483
- 3009189869
- 3015877656
- 3012234585
- 3009144915
- 3005619998
- 8031020
- 3004641308
- 8010252
- 3014833750
- 3024999441
- 3015200759
- 3006356043
- 3007410669
- 3004196040
- 9615005
- 1833920
- 3014976005
- 3007190523
- 3010303097
- 3031261833
- 3034599677
- 3042953190
- 1827096
- 3007366790
- 9617297
- 3010646402
- 3005641619
- 3004450489
- 1017294
- 3027614879
- 2249697
- 1649518
- 1123010
- 3015210830
- 3033589330
- 3009051471
- 2029315
- 3009169996
- 3004521401
- 3009063412
- 3010927122
- 3003597504
- 3013156185
- 3004635447
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