GMK HINGE— 510(k) K130299
Substantially EquivalentMedacta International
FDA 510(k) clearance K130299 for GMK HINGE, Substantially Equivalent on 2013-08-15. Applicant: Medacta International. Device class: 2.
Clearance details
- Applicant
- Medacta International
- Product code
- Code KRO
- Device class
- Class 2
- Regulation
- 21 CFR 888.3510
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Camarillo, CA, US
Recent devices under product code KRO
view allMore clearances from Medacta International
view allAdverse events under product code KRO
product code KRO- Death
- 19
- Injury
- 4,841
- Total
- 4,860
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 K130299
K-number listed on FDA's recall record- Z-2661-2017 — Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
- Z-0275-2016 — GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130299.
Data sourced from openFDA. This site is unofficial and independent of the FDA.