NEWDEAL TIBIAXYS SYSTEM— 510(k) K073375
Substantially EquivalentNewdeal Sas
FDA 510(k) clearance K073375 for NEWDEAL TIBIAXYS SYSTEM, Substantially Equivalent on 2008-02-21. Applicant: Newdeal Sas. Device class: 2.
Clearance details
- Applicant
- Newdeal Sas
- Product code
- Code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Planisboro, NJ, US
Recent devices under product code HRS
view allMore clearances from Newdeal Sas
view allAdverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
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 K073375
K-number listed on FDA's recall record- Z-0548-2022 — INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
- Z-1697-2014 — Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catalog number 285330S). Screws are provided in different diameters and lengths and are used to anchor various sizes and shapes of bone fixation plates when treating bone fractures or reconstruction of the ankle, foot or hand.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K073375.
Data sourced from openFDA. This site is unofficial and independent of the FDA.