ISSYS LP SPINAL FIXATION SYSTEM
FDA 510(k) clearance K111099 · decided 2011-05-05
Clearance details
- K-number
- K111099
- Device name
- ISSYS LP SPINAL FIXATION SYSTEM
- Applicant
- Custom Spine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-04-20
- Decision date
- 2011-05-05
- Days to decision
- 15 days
- Clearance type
- Special
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Parsippany, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile. recall (Z-1819-2013) | Custom Spine, Inc. | 2013-07-29 |