UNIVERSAL DRIVE SYSTEM
FDA 510(k) clearance K981269 · decided 1998-06-24
Clearance details
- K-number
- K981269
- Device name
- UNIVERSAL DRIVE SYSTEM
- Applicant
- Linvatec Corp.
- Decision
- Substantially Equivalent
- Date received
- 1998-04-07
- Decision date
- 1998-06-24
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Largo, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PRO5100, PowerPro Battery Modular Handpiece. Drill mode Nominal Speed Range: 0-1250 rpm, P recall (Z-1950-2009) | Linvatec Corp. dba ConMed Linvatec | 2009-10-01 |
| PowerProMax PRO5100M Battery Single Trigger, PowerProMax PRO5200M Battery Two Trigger, Pow recall (Z-1951-2009) | Linvatec Corp. dba ConMed Linvatec | 2009-10-01 |
| Mpower PRO6200 Single Trigger Modular Handpiece, Mpower PRO6202 Battery Two-Trigger Modula recall (Z-1952-2009) | Linvatec Corp. dba ConMed Linvatec | 2009-10-01 |