Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate— 510(k) K172502
Substantially EquivalentBiomet Manufacturing Corp
FDA 510(k) clearance K172502 for Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate, Substantially Equivalent on 2018-01-03. Applicant: Biomet Manufacturing Corp. Device class: 2.
Clearance details
- Applicant
- Biomet Manufacturing Corp
- 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
- Warsaw, IN, US
Recent devices under product code PHX
view allMore clearances from Biomet Manufacturing Corp
view allAdverse 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 K172502
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 K172502.
Data sourced from openFDA. This site is unofficial and independent of the FDA.