MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM— 510(k) K141989
Substantially EquivalentMako Surgical Corporation
FDA 510(k) clearance K141989 for MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM, Substantially Equivalent on 2014-11-13. Applicant: Mako Surgical Corporation. Device class: 2.
Clearance details
- Applicant
- Mako Surgical Corporation
- Product code
- Code OLO
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Fort Lauderdale, FL, US
Recent devices under product code OLO
view allMore clearances from Mako Surgical Corporation
view allAdverse events under product code OLO
product code OLO- Death
- 11
- Injury
- 2,799
- Malfunction
- 11,105
- Other
- 1
- Total
- 13,916
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 K141989
K-number listed on FDA's recall record- Z-2745-2020 — Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
- Z-3131-2017 — Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
- Z-1411-2017 — MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141989.
Data sourced from openFDA. This site is unofficial and independent of the FDA.