SMR Hybrid Glenoid System— 510(k) K163397
Substantially EquivalentLima Corporate S.P.A.
FDA 510(k) clearance K163397 for SMR Hybrid Glenoid System, Substantially Equivalent on 2017-06-29. Applicant: Lima Corporate S.P.A.. Device class: 2.
Clearance details
- Applicant
- Lima Corporate S.P.A.
- Product code
- Code MBF
- Device class
- Class 2
- Regulation
- 21 CFR 888.3670
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Villanova Di San Daniele Udine, IT
Recent devices under product code MBF
view all- K253592 — Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
- K251098 — Identity Revision Humeral Stems
- K250848 — Identity Shoulder System
- K240876 — Identity Shoulder System
- K233712 — PRIMA Humeral System; PRIMA TT Glenoid
More clearances from Lima Corporate S.P.A.
view allAdverse events under product code MBF
product code MBF- Injury
- 597
- Total
- 597
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 K163397
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 K163397.
Data sourced from openFDA. This site is unofficial and independent of the FDA.