SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWS— 510(k) K060736
Substantially EquivalentSmith & Nephew, Inc.
FDA 510(k) clearance K060736 for SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWS, Substantially Equivalent on 2006-04-18. Applicant: Smith & Nephew, Inc.. Device class: 2.
Clearance details
- Applicant
- Smith & Nephew, Inc.
- Product code
- Code HWC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Memphis, TN, US
Recent devices under product code HWC
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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 HWC
product code HWC- Death
- 20
- Injury
- 15,910
- Malfunction
- 8,192
- Other
- 1
- Total
- 24,123
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 K060736
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060736.
Data sourced from openFDA. This site is unofficial and independent of the FDA.