APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM— 510(k) K083607
Substantially EquivalentCayenne Medical, Inc.
FDA 510(k) clearance K083607 for APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM, Substantially Equivalent on 2009-03-04. Applicant: Cayenne Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Cayenne Medical, Inc.
- Product code
- Code HWC
- 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 HWC
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 HWC
product code HWC- Death
- 20
- Injury
- 15,910
- Malfunction
- 8,192
- Other
- 1
- Total
- 24,123
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.