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#
- 3010057495
- 3010370500
- 3007675948
- 3005809810
- 3030861184
- 3005194291
- 5906
- 3005467144
- 3010553238
- 3005974802
- 3009465247
- 1834379
- 3027615
- 3015179588
- 3004976965
- 3011499367
- 3025603301
- 3005641619
- 3013602181
- 2936485
- 3002858762
- 3017565094
- 3007307589
- 8010234
- 3003860763
- 9611616
- 3009882675
- 3013503739
- 3013011598
- 2085947
- 1721983
- 3005751028
- 3042235752
- 9613079
- 3002090132
- 8010871
- 8030607
- 3010408671
- 9680837
- 1643264
- 1417592
- 3008650117
- 9611813
- 9612277
- 3008132398
- 3013358456
- 3004111573
- 3005440795
- 8010877
- 1051526
- 3015895045
- 3009404219
- 1055890
- 2529846
- 3009973505
- 3006232063
- 1833053
- 3003675041
- 3012494290
- 8010099
- 8010697
- 3009996260
- 1824619
- 1416666
- 3004513872
- 3004598675
- 9616944
- 3023155873
- 9680424
- 3003803182
- 3016807211
- 3024988980
- 3032847175
- 3022748632
- 2648623
- 8010252
- 3009499159
- 9611579
- 3036756245
- 9614986
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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