VERITAS COLLAGEN MATRIX— 510(k) K062915
Substantially EquivalentSynovis Surgical Innovations
FDA 510(k) clearance K062915 for VERITAS COLLAGEN MATRIX, Substantially Equivalent on 2006-12-06. Applicant: Synovis Surgical Innovations. Device class: 2.
Clearance details
- Applicant
- Synovis Surgical Innovations
- Product code
- Code FTM
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Paul, MN, US
Recent devices under product code FTM
view allMore clearances from Synovis Surgical Innovations
view all- K122306 — SYNOVIS COLLAGEN MATRIX (TBD)
- K083039 — VERITAS COLLAGEN MATRIX (DRY)
- 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 FTM
product code FTM- Death
- 17
- Injury
- 2,174
- Total
- 2,191
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 →
Recalls naming K062915
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 K062915.
Data sourced from openFDA. This site is unofficial and independent of the FDA.