GMK Sphere & GMK SpheriKA Cementless
Summary
Medacta International S.A. received 510(k) clearance for GMK Sphere & GMK SpheriKA Cementless, a MBH device. Cleared on 2023-01-20.
Details
Source
510(k) Clearance
External ID
K223548
Action Date
2023-01-20
Status
Traditional
Category
device
Product Code
MBH
Product Description
GMK Sphere & GMK SpheriKA Cementless. Product code: MBH.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Medacta International S.A. has received 58 total clearances in our database.
Medacta International S.A. has 58 FDA actions in our database, including 58 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Medacta International S.A. have FDA actions?
Medacta International S.A. has 58 FDA actions in our database, including 0 recalls and 58 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K223548" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29