DeviceClearance

Tornier Perform Patient-Matched Primary Reversed Glenoid and BLUEPRINT Patient Specific Instrumentation— 510(k) K211359

Substantially Equivalent

Tornier, Inc.

FDA 510(k) clearance K211359 for Tornier Perform Patient-Matched Primary Reversed Glenoid and BLUEPRINT Patient Specific Instrumentation, Substantially Equivalent on 2021-11-12. Applicant: Tornier, Inc.. Device class: 2.

Clearance details

Applicant
Tornier, Inc.
Product code
Code PHX
Device class
Class 2
Regulation
21 CFR 888.3660
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bloomington, MN, US
Download summary PDFView on FDA.gov ↗

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More clearances from Tornier, Inc.

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Adverse events under product code PHX

product code PHX
Death
10
Injury
9,705
Malfunction
1,252
Total
10,967

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 K211359

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 K211359.

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