APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM— 510(k) K083612
Substantially EquivalentCayenne Medical, Inc.
FDA 510(k) clearance K083612 for APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM, 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 →
Recalls naming K083612
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 K083612.
Data sourced from openFDA. This site is unofficial and independent of the FDA.