SYNTHES HEMOSTATIC BONE PUTTY
FDA 510(k) clearance K113079 · decided 2011-12-13
Clearance details
- K-number
- K113079
- Device name
- SYNTHES HEMOSTATIC BONE PUTTY
- Applicant
- Synthes (Usa) Products, LLC/Norian Corporation
- Decision
- Substantially Equivalent
- Date received
- 2011-10-17
- Decision date
- 2011-12-13
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- MTJ
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- West Chester, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the cont recall (Z-1094-2015) | Synthes, Inc. | 2015-02-11 |
| Synthes(R) Hemostatic Bone Putty, Part numbers 08.901.001.97S, 08.901.001.98S, 08.901.001. recall (Z-2206-2012) | Synthes USA HQ, Inc. | 2012-08-16 |