SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM
FDA 510(k) clearance K993335 · decided 2000-06-12
Clearance details
- K-number
- K993335
- Device name
- SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM
- Applicant
- Synthes (Usa)
- Decision
- Substantially Equivalent
- Date received
- 1999-10-04
- Decision date
- 2000-06-12
- Days to decision
- 252 days
- Clearance type
- Traditional
- Product code
- HTO
- Device class
- 1
- Regulation number
- 888.4540
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Paoli, PA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Synthes (Usa)
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 |
|---|---|---|
| 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 |
| 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 |
| FLEXIBLE REAMER, GUIDE WIRE SYSTEM (K790307) | 3M Company | 1979-02-22 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NORIAN SRS BONE CEMENT (P970010/S004) | Synthes (Usa) | 2000-08-31 |
| NORIAN SRS CEMENT (P970010/S002) | Synthes (Usa) | 2000-04-28 |
| NORIAN SRS CEMENT (P970010/S001) | Synthes (Usa) | 1999-07-16 |
| NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT (P970010) | Synthes (Usa) | 1998-12-23 |