REPROCESSED ARTHROSCOPIC SHAPERS
FDA 510(k) clearance K012667 · decided 2002-06-03
Clearance details
- K-number
- K012667
- Device name
- REPROCESSED ARTHROSCOPIC SHAPERS
- Applicant
- Surgical Instruments Service and Savings, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-08-13
- Decision date
- 2002-06-03
- Days to decision
- 294 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Phoenix, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| - Abrader Bur, Round (Aqua) 4.0mm Ref. 7205324 Lot 123270 - AcromioBlaster Burr (Brick Red recall (Z-1633-2013) | Surgical Instrument Service And Savings, Inc. | 2013-07-01 |
| - CLEAR-TRAC COMPLETE, Threaded Cannula with Obturator, (Grey) 7.0mm x 72mm Ref. 72200905 recall (Z-1641-2013) | Surgical Instrument Service And Savings, Inc. | 2013-07-01 |