SYNTHES HEMOSTATIC BONE PUTTY— 510(k) K113079
Substantially EquivalentSynthes (Usa) Products, LLC/Norian Corporation
FDA 510(k) clearance K113079 for SYNTHES HEMOSTATIC BONE PUTTY, Substantially Equivalent on 2011-12-13. Applicant: Synthes (Usa) Products, LLC/Norian Corporation. Device class: Unclassified.
Clearance details
- Applicant
- Synthes (Usa) Products, LLC/Norian Corporation
- 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
Recent devices under product code MTJ
view all- K262769 — Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)
- K261439 — Permatage Flowable, Settable Hemostatic Bone Paste
- K232998 — Montage- XT Settable, Resorbable Hemostatic Bone Putty
- K213418 — MONTAGE Settable, Resorbable Hemostatic Bone Putty
- K231386 — Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste
Recalls naming K113079
K-number listed on FDA's recall record- Z-2206-2012 — Synthes(R) Hemostatic Bone Putty, Part numbers 08.901.001.97S, 08.901.001.98S, 08.901.001.99S, 08.901.001D, and VB1025.10S. Indicated for use as a water soluble implant material and for use in the control of bleeding from bone surfaces.
- Z-1094-2015 — Hemostatic Bone Putty, for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113079.
Data sourced from openFDA. This site is unofficial and independent of the FDA.