TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW— 510(k) K981529
Substantially EquivalentSmith & Nephew, Inc.
FDA 510(k) clearance K981529 for TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW, Substantially Equivalent on 1998-07-09. Applicant: Smith & Nephew, Inc.. Device class: 2.
Clearance details
- Applicant
- Smith & Nephew, Inc.
- Product code
- Code JDS
- 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
Recent devices under product code JDS
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- K254084 — AETOS Shoulder System - CONCELOC Glenoids
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Adverse events under product code JDS
product code JDS- Injury
- 1,776
- Malfunction
- 1,509
- Total
- 3,285
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 K981529
K-number listed on FDA's recall record- Z-0943-2013 — INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 80 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation.
- Z-0944-2013 — INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 75 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K981529.
Data sourced from openFDA. This site is unofficial and independent of the FDA.