FLEXIBLE REAMER, GUIDE WIRE SYSTEM
FDA 510(k) clearance K790307 · decided 1979-02-22
Clearance details
- K-number
- K790307
- Device name
- FLEXIBLE REAMER, GUIDE WIRE SYSTEM
- Applicant
- 3M Company
- Decision
- Substantially Equivalent
- Date received
- 1979-02-13
- Decision date
- 1979-02-22
- Days to decision
- 9 days
- Clearance type
- Traditional
- Product code
- HTO
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- White City, OR, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SYNTHES RIA SYSTEM (EXPANDED INDICATIONS) (K111437) | Synthes (USA) Products, LLC | 2011-08-10 |
| SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS (K042899) | Synthes (Usa) | 2005-03-16 |
| MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM (K013527) | Synthes (Usa) | 2001-12-21 |
| SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM (K993335) | Synthes (Usa) | 2000-06-12 |
| FLEXIBLE INTRAMEDULLARY REAMER (K954915) | Zimmer, Inc. | 1995-12-28 |
| COMBINATION REAMER (K903248) | Onyx Medical Corp. | 1990-07-30 |
| MCCONNELL REAMER GUIDE (K885100) | Mcconnell Orthopedic | 1989-01-13 |
| WARSAW ORTHOPEDIC POINTED REAMER (K870845) | Warsaw Orthopedic, Inc. | 1987-03-11 |
| ABC-1000 SMALL JOINT REAMERS (K862933) | Instrumentation Industries, Inc. | 1986-08-18 |
| MULTIPLE MANUAL SURGICAL INSTRUMENTS (K832686) | Hirata Sangyo Co. USA, Inc. | 1983-10-14 |
| MEDULLARY CANAL SCRAPERS (K811081) | The Anspach Effort, Inc. | 1981-04-29 |
| C.C.F. FEMORAL DEBRIDEMENT PROBE (K790996) | Depuy, Inc. | 1979-06-27 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S011) | 3M Company | 1994-11-28 |
| CENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S010) | 3M Company | 1994-05-19 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S006) | 3M Company | 1992-12-31 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S009) | 3M Company | 1992-03-13 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S008) | 3M Company | 1992-01-28 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S007) | 3M Company | 1990-10-17 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S005) | 3M Company | 1990-03-08 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S004) | 3M Company | 1989-11-22 |