SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION— 510(k) K123598
Substantially EquivalentSmith & Nephew, Inc.
FDA 510(k) clearance K123598 for SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION, Substantially Equivalent on 2013-06-28. Applicant: Smith & Nephew, Inc.. Device class: 2.
Clearance details
- Applicant
- Smith & Nephew, Inc.
- Product code
- Code JDI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3350
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cordova, TN, US
Recent devices under product code JDI
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- K241716 — Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component
More clearances from Smith & Nephew, Inc.
view all- K261462 — LANDMARK Total Knee System
- K261968 — Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981) +1 more
- DEN250037 — TESSA Spatial Surgery System; INTELLIO Tablet (72205455)
- K254084 — AETOS Shoulder System - CONCELOC Glenoids
- K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 0
Adverse events under product code JDI
product code JDI- Death
- 65
- Injury
- 12,943
- Malfunction
- 1,681
- Total
- 14,689
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 K123598
K-number listed on FDA's recall record- Z-0730-2019 — SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
- Z-1008-2017 — REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123598.
Data sourced from openFDA. This site is unofficial and independent of the FDA.