SYNOVIS COLLAGEN MATRIX (TBD)— 510(k) K122306
Substantially EquivalentSynovis Surgical Innovations
FDA 510(k) clearance K122306 for SYNOVIS COLLAGEN MATRIX (TBD), Substantially Equivalent on 2013-03-08. Applicant: Synovis Surgical Innovations. Device class: 2.
Clearance details
- Applicant
- Synovis Surgical Innovations
- Product code
- Code DXZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.3470
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Paul, MN, US
Recent devices under product code DXZ
view allMore clearances from Synovis Surgical Innovations
view all- K083039 — VERITAS COLLAGEN MATRIX (DRY)
- K062915 — VERITAS COLLAGEN MATRIX
- K041669 — VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD
- K040415 — PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT
- K040119 — PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATION
Adverse events under product code DXZ
product code DXZ- Death
- 19
- Injury
- 265
- Total
- 284
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.