SYNTHES HEMOSTATIC BONE PUTTY (HBP)
FDA 510(k) clearance K103822 · decided 2011-05-19
Clearance details
- K-number
- K103822
- Device name
- SYNTHES HEMOSTATIC BONE PUTTY (HBP)
- Applicant
- Synthes USA Products, LLC
- Decision
- Substantially Equivalent
- Date received
- 2010-12-30
- Decision date
- 2011-05-19
- Days to decision
- 140 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 |
|---|---|---|
| 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 |