INTEGRATED DRIVE/PUMP SYSTEM
FDA 510(k) clearance K981636 · decided 1998-08-20
Clearance details
- K-number
- K981636
- Device name
- INTEGRATED DRIVE/PUMP SYSTEM
- Applicant
- Linvatec Corp.
- Decision
- Substantially Equivalent
- Date received
- 1998-05-08
- Decision date
- 1998-08-20
- Days to decision
- 104 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 |
|---|---|---|
| Ultra Power Burs, Sterile, Single-Use. recall (Z-0041-05) | Linvatec Corp. | 2004-10-23 |