LABRALINK SUTURE ANCHOR WITH INSERTER, 2.9MM PER-LOADED WITH ONE (1) AND (2) #2 UHMWPE SUTURE— 510(k) K112960
Substantially EquivalentCayenne Medical, Inc.
FDA 510(k) clearance K112960 for LABRALINK SUTURE ANCHOR WITH INSERTER, 2.9MM PER-LOADED WITH ONE (1) AND (2) #2 UHMWPE SUTURE, Substantially Equivalent on 2012-01-09. Applicant: Cayenne Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Cayenne Medical, Inc.
- Product code
- Code MBI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Scottsdale, AZ, US
Recent devices under product code MBI
view allMore clearances from Cayenne Medical, Inc.
view all- K180274 — Ventix Link Knotless Anchor with Inserter
- K172186 — BioWick X Implant with Driver
- K161033 — AFX Femoral Implant With Inserter
- K151068 — SureLock W Suture Anchor
- K143473 — Short SureLock All-Suture Anchor, 1.4mm with (1) size 0 UHMWPE suture with needles, Short SureLock All-Suture Anchor, 1.4mm with (1) size 2-0 UHMWPE suture with needles
Adverse events under product code MBI
product code MBI- Injury
- 3,163
- Malfunction
- 13,006
- Other
- 2
- Total
- 16,171
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.