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#
- 2249615
- 1221934
- 3011749806
- 3008951116
- 3009380063
- 3005304945
- 3011070496
- 2431166
- 3006232063
- 9617544
- 3010326971
- 2029275
- 3004111573
- 1000432246
- 3026771806
- 9611274
- 3010057495
- 3012447612
- 2648623
- 3015648612
- 3010386387
- 3012523063
- 3004635447
- 3010123256
- 3009149199
- 3032747418
- 3042765769
- 1835831
- 3004638600
- 3008285983
- 3005621335
- 3017486146
- 3009532798
- 1836161
- 3003724410
- 3020650900
- 3011189525
- 3000931034
- 3024856795
- 3023808054
- 3031261833
- 9611616
- 2437731
- 9616250
- 3008388245
- 2032098
- 3007289746
- 3009998573
- 3013730328
- 3003973936
- 3003387384
- 3031564283
- 3007583504
- 3013462427
- 3004450489
- 1424434
- 3004049923
- 3031024716
- 3005819474
- 3013540005
- 3012697315
- 3023443842
- 1226191
- 2434839
- 9611827
- 3006809628
- 3006493760
- 3043543260
- 3034525
- 3022320321
- 3027344440
- 3015167917
- 3004549189
- 1424785
- 2024024
- 3010673850
- 3008021110
- 3003403260
- 3010269591
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