SMITH & NEPHEW VARIABLE-ANGLE LOCKING MINI-FRAGMENT PLATING SYSTEM— 510(k) K132886
Substantially EquivalentSmith & Nephew, Inc.
FDA 510(k) clearance K132886 for SMITH & NEPHEW VARIABLE-ANGLE LOCKING MINI-FRAGMENT PLATING SYSTEM, Substantially Equivalent on 2014-02-04. Applicant: Smith & Nephew, Inc.. Device class: 2.
Clearance details
- Applicant
- Smith & Nephew, 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
- Memphis, TN, US
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Adverse 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 K132886
K-number listed on FDA's recall record- Z-0396-2018 — smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442024, QTY: (1), STERILE R Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System (VLP MINI-MOD) are intended for use in internal fixation of small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.
- Z-0397-2018 — smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STOUT STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442030, QTY: (1), STERILE R Bone plates and bone screws from the Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System (VLP MINI-MOD) are intended for use in internal fixation of small bones and small bone fragments and non-load bearing stabilization and reduction of bone fragments in long bones.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132886.
Data sourced from openFDA. This site is unofficial and independent of the FDA.