SYNTHES HEMOSTATIC BONE PUTTY (HBP)— 510(k) K103822
Substantially EquivalentSynthes USA Products, LLC
FDA 510(k) clearance K103822 for SYNTHES HEMOSTATIC BONE PUTTY (HBP), Substantially Equivalent on 2011-05-19. Applicant: Synthes USA Products, LLC. Device class: Unclassified.
Clearance details
- Applicant
- Synthes USA Products, LLC
- Product code
- Code MTJ
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Chester, PA, US
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- K231386 — Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste
More clearances from Synthes USA Products, LLC
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Recalls naming K103822
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103822.
Data sourced from openFDA. This site is unofficial and independent of the FDA.