510(k) K901289
- Device
- RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS
- Applicant
- MUMTAZ I. MALIK
- 510(k) number
- K901289
- Product code
- LXH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-09-28
- Date received
- 1990-03-20
- Regulation
- 888.4540
- Classification name
- Orthopedic Manual Surgical Instrument
- Medical specialty
- Orthopedic
- 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 LXH #
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|---|---|---|---|
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| K140414 | IMBIBE NEEDLE | Orthovita, Inc. | 2014-04-01 |
| K101609 | SELF RETAINING SOFT TISSUE RETRACTOR | Koros USA, Inc. | 2010-12-09 |
| K001507 | MICROPERFORATION INSTRUMENT | Smith & Nephew, Inc. | 2000-06-14 |
| K952495 | ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM | Orthopedic Systems, Inc. | 1996-01-22 |
| K943873 | ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY | Orthomet, Inc. | 1995-04-26 |
| K944188 | SPINAL MARKER | Leibinger L.P. | 1995-04-13 |
| K941896 | STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR | Depuy, Inc. | 1994-11-07 |
| K941711 | HYPERFLEX FLEXIBLE GUIDEWIRES | Linvatec Corp. | 1994-08-26 |
| K941605 | STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH | Stryker Corp. | 1994-08-05 |
| K933772 | PUNCH SURGICAL | Mahe-Medizintechnik | 1994-02-01 |
| K933242 | SOFAMOR ORTHOPAEDIC INSTRUMENTS | Danek Medical, Inc. | 1994-01-28 |
| K934260 | BARRIER BONE WAX APPLICATOR | Phillips Pharmaceuticals, Inc. | 1994-01-26 |
| K931846 | BIO-PREP | Biomedical Devices, Inc. | 1994-01-21 |
| K930028 | CALMPS: BONE, MASTIN, LEWIN, BRAND | Thomasville Medical Assoc. | 1993-02-16 |
Legacy Summary#
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FDA Review#
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