ANATOMIC LOCKING PLATING SYSTEM— 510(k) K082300
Substantially EquivalentDePuy Orthopaedics, Inc.
FDA 510(k) clearance K082300 for ANATOMIC LOCKING PLATING SYSTEM, Substantially Equivalent on 2009-02-18. 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 K082300
K-number listed on FDA's recall record- Z-0450-2016 — A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones.
- Z-0716-2014 — Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082300.
Data sourced from openFDA. This site is unofficial and independent of the FDA.