MAXTORQUE MINI CANNULATED SCREW SYSTEM— 510(k) K082574
Substantially EquivalentOrthohelix Surgical Designs, Inc.
FDA 510(k) clearance K082574 for MAXTORQUE MINI CANNULATED SCREW SYSTEM, Substantially Equivalent on 2008-12-08. Applicant: Orthohelix Surgical Designs, Inc.. Device class: 2.
Clearance details
- Applicant
- Orthohelix Surgical Designs, 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
- Special
- Location
- Akron, OH, US
Recent devices under product code HWC
view allMore clearances from Orthohelix Surgical Designs, 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 K082574
K-number listed on FDA's recall record- Z-0026-2013 — OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
- Z-0027-2013 — OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082574.
Data sourced from openFDA. This site is unofficial and independent of the FDA.