HEMASORBPLUS Resorbable Hemostatic Bone Putty
FDA 510(k) clearance K153317 · decided 2016-11-30
Clearance details
- K-number
- K153317
- Device name
- HEMASORBPLUS Resorbable Hemostatic Bone Putty
- Applicant
- Orthocon, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-11-18
- Decision date
- 2016-11-30
- Days to decision
- 378 days
- Clearance type
- Traditional
- Product code
- MTJ
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Irvington, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.