FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

131 results for "Medacta USA"
73–96 of 131
Search insights Median review: 93d Cleared: 100% Top manufacturer: Medacta International S.A. Lead specialty: Orthopedic
Cleared Mar 26, 2021
FairFix Adjustable Button System
K203259 · MBI
Medacta International S.A.
Orthopedic · 141d
Cleared Mar 02, 2021
GMK Revision & Hinge Extension - TiNbN Coating
K210010 · KRO
Medacta International S.A.
Orthopedic · 57d
Cleared Mar 02, 2021
Shoulder System - TiNbN Coating
K203755 · PHX
Medacta International S.A.
Orthopedic · 69d
Cleared Feb 22, 2021
MectaLock Extension
K203493 · MAI
Medacta International S.A.
Orthopedic · 87d
Cleared Feb 19, 2021
MyPAO Planning Report
K200589 · LLZ
Medacta International S.A.
Radiology · 350d
Cleared Feb 12, 2021
MectaLIF Transforaminal TiPEEK
K200551 · MAX
Medacta Inernational SA
Orthopedic · 346d
Cleared Jan 26, 2021
M.U.S.T. Pedicle Screw Extension and Long Tab Implants
K203482 · NKB
Medacta International S.A.
Orthopedic · 60d
Cleared Jan 19, 2021
SnugFit All-Suture Anchor
K203485 · MBI
Medacta International S.A.
Orthopedic · 53d
Cleared Jan 13, 2021
M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
K203671 · OUR
Medacta International S.A.
Orthopedic · 28d
Cleared Jan 11, 2021
M-Vizion Femoral Revision System Extension
K201471 · LZO
Medacta International S.A.
Orthopedic · 222d
Cleared Dec 28, 2020
Quadra-P
K202730 · LZO
Medacta International S.A.
Orthopedic · 101d
Cleared Dec 11, 2020
GMK Total Knee System - TiNbN Coating
K202684 · JWH
Medacta International S.A.
Orthopedic · 87d
Cleared Dec 02, 2020
SMS Cementless Stem
K203041 · LZO
Medacta International S.A.
Orthopedic · 57d
Cleared Nov 16, 2020
M.U.S.T. MINI Posterior Cervical Screws System
K203149 · NKG
Medacta International S.A.
Orthopedic · 25d
Cleared Nov 06, 2020
Mecta-C Stand Alone Extension
K203076 · OVE
Medacta International S.A.
Orthopedic · 24d
Cleared Nov 04, 2020
MyHip Planner & Verifier
K200350 · LLZ
Medacta International S.A.
Radiology · 266d
Cleared Oct 27, 2020
NextAR TKA Platform
K202152 · SBF
Medacta International S.A.
Orthopedic · 85d
Cleared Oct 05, 2020
MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides
K200792 · PQC
Medacta Inernational SA
Orthopedic · 193d
Cleared Oct 01, 2020
MectaScope System
K200067 · HRX
Medacta International S.A.
Orthopedic · 262d
Cleared Sep 18, 2020
GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made...
K202022 · JWH
Medacta International S.A.
Orthopedic · 58d
Cleared Sep 18, 2020
SMS Cementless Stem
K201673 · LZO
Medacta International S.A.
Orthopedic · 91d
Cleared Aug 11, 2020
Lateralized Glenosphere
K193175 · PHX
Medacta Inernational SA
Orthopedic · 267d
Cleared Jul 10, 2020
NextAR TKA Platform
K193559 · SBF
Medacta Inernational SA
Orthopedic · 200d
Cleared Apr 29, 2020
M-Vizion Femoral Revision System Extension
K191816 · LZO
Medacta International S.A.
Orthopedic · 299d