DeviceClearance

SMITH & NEPHEW TWINFIX ULTRA HA SUTURE ANCHOR— 510(k) K093844

Substantially Equivalent

Smith & Nephew, Inc.

FDA 510(k) clearance K093844 for SMITH & NEPHEW TWINFIX ULTRA HA SUTURE ANCHOR, Substantially Equivalent on 2010-04-01. Applicant: Smith & Nephew, Inc.. Device class: 2.

Clearance details

Applicant
Smith & Nephew, Inc.
Product code
Code MAI
Device class
Class 2
Regulation
21 CFR 888.3030
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mansfield, MA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MAI

product code MAI
Injury
1,948
Malfunction
8,580
Total
10,528

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 K093844

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093844.

Data sourced from openFDA. This site is unofficial and independent of the FDA.