510(k) K043602
- Device
- QUADRANT RETRACTOR SYSTEM
- Applicant
- MEDTRONIC SOFAMOR DANEK
- 510(k) number
- K043602
- Product code
- GAD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-02-23
- Date received
- 2004-12-29
- Regulation
- 878.4800
- Classification name
- Retractor
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD TREHARNE
- Address
- 1800 Pyramid Pl. Memphis TN US 38132 38132
FDA Registration Numbers#
- 2184009
- 1221934
- 3044322716
- 3009380063
- 3005580113
- 2431166
- 3006232063
- 3006787036
- 3004111573
- 9611274
- 3018984
- 3010057495
- 3012447612
- 3016807211
- 2648623
- 3010386387
- 3032747418
- 3010123256
- 3011371465
- 3004638600
- 3008285983
- 3007840839
- 3024988980
- 3000296634
- 1836161
- 3000931034
- 9611616
- 9616250
- 3027815
- 3009998573
- 9681622
- 3009499159
- 3005194291
- 3021006167
- 3012185136
- 3031564283
- 3038295170
- 3004450489
- 3009420598
- 3004049923
- 3018783415
- 3022748632
- 2434839
- 8030607
- 9611827
- 1416666
- 3002761766
- 3008902714
- 8043746
- 3022320321
- 3005467144
- 3015167917
- 3005587147
- 3004519921
- 1836116
- 3009540749
- 8010252
- 3006487092
- 3009417901
- 3015179588
- 3011795235
- 8040233
- 1315756
- 3003955307
- 1223656
- 3009468807
- 1061124
- 3035858921
- 8010704
- 3012507533
- 3005809810
- 2521453
- 2529846
- 3010594904
- 1420054
- 2648727
- 9680002
- 1055236
- 8010935
Source Documents#
Other 510(k) Records For Product Code GAD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K152538 | JRP Wound Spreader | J.R. Parker, LLC | 2016-04-13 |
| K151104 | OTELO LL | Spineart | 2016-01-06 |
| K132645 | THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES | Medtronic, Inc. | 2013-10-04 |
| K071775 | DASH | Ezsurgical | 2007-08-07 |
| K050256 | APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR | Apple Medical Corp. | 2005-04-26 |
| K001339 | MRI FASTSYSTEM RETRACTOR SYSTEM | Omni-Tract Surgical, Div. Minn. Scientific, Inc. | 2000-05-17 |
| K980588 | CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 | Clarus Medical Systems, Inc. | 1998-08-18 |
| K963006 | SCION SAPHENOUS VEIN HARVESTING SYSTEM | Scion International, Inc. | 1996-09-20 |
| K943875 | VILLALTA RETRACTOR | Hct, Inc. | 1994-11-09 |
| K942002 | RETRACTOR | Automated Medical Products Corp. | 1994-05-17 |
| K941448 | RETRACTOR | Technovations | 1994-04-15 |
| K930316 | LUNG RETRACTORS: DAVIDSON, SEMB | Thomasville Medical Assoc. | 1994-02-10 |
| K926585 | THOROCOSCOPY SELF-RETAINING RETRACTOR | T. Korossurgical Instruments Corp. | 1993-08-06 |
| K921017 | HARGIS SR2 SELF-RETRACTION SYSTEM | Medin Corp. | 1993-07-02 |
| K921019 | HARGIS RECTAL SELF RETRATION SYSTEM | Medin Corp. | 1993-07-02 |
Legacy Summary#
summary
FDA Review#
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