IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM— 510(k) K101700
Substantially EquivalentExtremity Medical, LLC
FDA 510(k) clearance K101700 for IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM, Substantially Equivalent on 2010-10-12. Applicant: Extremity Medical, LLC. Device class: 2.
Clearance details
- Applicant
- Extremity Medical, LLC
- 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
- Parsippany, NJ, US
Recent devices under product code HWC
view allMore clearances from Extremity Medical, LLC
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 K101700
K-number listed on FDA's recall record- Z-0752-2013 — Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. This screw measuring device is an accessory to the IO FiX Screw and Washer System that is used to measure the length of the screw by placing the depth gauge over the guidewire and down to the bone. Orthopedic device.
- Z-0344-2013 — IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079. The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand and wrist.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101700.
Data sourced from openFDA. This site is unofficial and independent of the FDA.