KRYPTONITE BONE CEMENT
FDA 510(k) clearance K091382 · decided 2009-11-16
Clearance details
- K-number
- K091382
- Device name
- KRYPTONITE BONE CEMENT
- Applicant
- Doctors Research Group, Inc.
- Decision
- Unknown
- Date received
- 2009-05-11
- Decision date
- 2009-11-16
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- GXP
- Device class
- 2
- Regulation number
- 882.5300
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Doctors Research Group Kryptonite Bone Cement packaged in 5cc and 10 cc Kits: Product Code recall (Z-1496-2012) | Doctor's Research Group, Inc. | 2012-05-08 |