LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM— 510(k) K083843
Substantially EquivalentDePuy Orthopaedics, Inc.
FDA 510(k) clearance K083843 for LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM, Substantially Equivalent on 2009-03-20. Applicant: DePuy Orthopaedics, Inc.. Device class: 2.
Clearance details
- Applicant
- DePuy Orthopaedics, Inc.
- 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
- Warsaw, IN, US
Recent devices under product code HRS
view allMore clearances from DePuy Orthopaedics, Inc.
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 K083843
K-number listed on FDA's recall record- Z-2308-2020 — A.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm, Item Number: 110017628 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
- Z-2310-2020 — A.L.P.S. T15 Multi-Directional Locking Screw 3.5mm x 60mm, Item Number: 110017960 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K083843.
Data sourced from openFDA. This site is unofficial and independent of the FDA.