ADVANCED TURBO DRIVE SYSTEM
FDA 510(k) clearance K050519 · decided 2005-05-17
Clearance details
- K-number
- K050519
- Device name
- ADVANCED TURBO DRIVE SYSTEM
- Applicant
- Linvatec Corp.
- Decision
- Substantially Equivalent
- Date received
- 2005-03-01
- Decision date
- 2005-05-17
- Days to decision
- 77 days
- Clearance type
- Special
- Product code
- GEY
- Device class
- 1
- Regulation number
- 878.4820
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Largo, FL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Linvatec Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS (K020621) | Arthrocare Corp. | 2002-03-28 |
| SYMPHONY GRAFT DELIVERY SYSTEM (GDS) (K012738) | Depuyacromed | 2001-11-14 |
| MEDNEXT 1000 DRILL (K972308) | Mednext, Inc. | 1997-08-20 |
| AQUA SPRAY (K971941) | Boyd Industries, Inc. | 1997-08-14 |
| BONE AND MARROW COLLECTION SYSTEM KIT (K971782) | Biomedical Ent., Inc. | 1997-07-29 |
| BONE & MARROW CLLECTION SYSTEM (K971268) | Biomedical International Corp. | 1997-07-03 |
| ORTHOCHUCK (K964252) | Buckman Co., Inc. | 1997-05-27 |
| ANSPACH LUBRICATING SYSTEM II (K970530) | The Anspach Effort, Inc. | 1997-05-05 |
| BME BONE DRILL BITS (K964073) | Biomedical Ent., Inc. | 1996-11-14 |
| SURGICAL KIT-ACUFEX MOSAICPLASTY SYSTEM (K962789) | Smith & Nephew Endoscopy, Inc. | 1996-08-14 |
| BONE & MARROW COLLECTION SYSTEM (K961901) | Biomedical Ent., Inc. | 1996-08-06 |
| SURGIMOTOR (K954470) | W.O.M. World of Medicine GmbH | 1995-12-08 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function as recall (Z-0916-2013) | Linvatec Corp. dba ConMed Linvatec | 2013-03-06 |
| D3000I Advantage Drive System, 230v, surgical instrument motor. Product Usage: The Advanta recall (Z-0917-2013) | Linvatec Corp. dba ConMed Linvatec | 2013-03-06 |