G7 ACETABULAR SYSTEM— 510(k) K121874
Substantially EquivalentBiomet Manufacturing Corp
FDA 510(k) clearance K121874 for G7 ACETABULAR SYSTEM, Substantially Equivalent on 2012-11-23. Applicant: Biomet Manufacturing Corp. Device class: 2.
Clearance details
- Applicant
- Biomet Manufacturing Corp
- Product code
- Code PBI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3310
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code PBI
view allMore clearances from Biomet Manufacturing Corp
view allAdverse events under product code PBI
product code PBI- Injury
- 499
- Malfunction
- 729
- Total
- 1,228
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 K121874
K-number listed on FDA's recall record- Z-0007-2023 — G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
- Z-1837-2014 — G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.
- Z-1838-2014 — G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121874.
Data sourced from openFDA. This site is unofficial and independent of the FDA.