QUADRANT RETRACTOR SYSTEM
FDA 510(k) clearance K043602 · decided 2005-02-23
Clearance details
- K-number
- K043602
- Device name
- QUADRANT RETRACTOR SYSTEM
- Applicant
- Medtronic Sofamor Danek
- Decision
- Substantially Equivalent
- Date received
- 2004-12-29
- Decision date
- 2005-02-23
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- GAD
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| JRP Wound Spreader (K152538) | J.R. Parker, LLC | 2016-04-13 |
| OTELO LL (K151104) | Spineart | 2016-01-06 |
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| DASH (K071775) | Ezsurgical | 2007-08-07 |
| APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR (K050256) | Apple Medical Corp. | 2005-04-26 |
| MRI FASTSYSTEM RETRACTOR SYSTEM (K001339) | Omni-Tract Surgical, Div. Minn. Scientific, Inc. | 2000-05-17 |
| CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 (K980588) | Clarus Medical Systems, Inc. | 1998-08-18 |
| SCION SAPHENOUS VEIN HARVESTING SYSTEM (K963006) | Scion International, Inc. | 1996-09-20 |
| VILLALTA RETRACTOR (K943875) | Hct, Inc. | 1994-11-09 |
| RETRACTOR (K942002) | Automated Medical Products Corp. | 1994-05-17 |
| RETRACTOR (K941448) | Technovations | 1994-04-15 |
| LUNG RETRACTORS: DAVIDSON, SEMB (K930316) | Thomasville Medical Assoc. | 1994-02-10 |
Recalls involving this device
No recalls on record reference this clearance.