FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE)— 510(k) K131591
Substantially EquivalentPega Medical, Inc.
FDA 510(k) clearance K131591 for FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE), Substantially Equivalent on 2013-11-27. Applicant: Pega Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Pega 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
- Laval, CA
Recent devices under product code HWC
view allMore clearances from Pega Medical, Inc.
view allAdverse 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 K131591
K-number listed on FDA's recall record- Z-0324-2016 — SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This instrument is included in the Free Gliding SCFE Screw System instrument tray. This instrument is marked with the catalogue number and lot number. The Free-Gliding SCFE Screw System is a temporary implant for stabilization of pediatric femoral neck fractures and slipped capital femoral epiphysis (SCFE) in pediatric patients. Orthopedic.
- Z-1848-2015 — Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131591.
Data sourced from openFDA. This site is unofficial and independent of the FDA.