TORNIER, INC., INSITE SUTURE ANCHORS— 510(k) K083268
Substantially EquivalentTornier, Inc.
FDA 510(k) clearance K083268 for TORNIER, INC., INSITE SUTURE ANCHORS, Substantially Equivalent on 2009-02-12. Applicant: Tornier, Inc.. Device class: 2.
Clearance details
- Applicant
- Tornier, Inc.
- Product code
- Product code MAI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beverly, MA, US
Recent devices under product code MAI
view allMore clearances from Tornier, Inc.
view all- K263583 — Tornier Humeral Reconstruction System (HRS) Tuberosity Body
- K260721 — Tornier Perform Advanced Glenoid
- K252788 — Tornier Perform Reversed Monopost Glenoid (Perform Mono)
- K251686 — Tornier Humeral Reconstruction System Max (Tornier HRS Max)
- K230352 — Tornier Humeral Nail and Tornier Long Humeral Nail
Adverse events under product code MAI
product code MAI- Injury
- 1,948
- Malfunction
- 8,580
- Total
- 10,528
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.