Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

208 results for "Medacta International"
121–144 of 208
Search insights Median review: 93d Cleared: 100% Top manufacturer: Medacta International S.A. Lead specialty: Orthopedic
Cleared Oct 22, 2018
Quadra P
K181254 · LZO
Medacta International S.A.
Orthopedic · 164d
Cleared Aug 23, 2018
GMK Sphere CR Tibial Inserts
K181635 · JWH
Medacta International S.A.
Orthopedic · 63d
Cleared Aug 23, 2018
GMK Sphere - Kinematic Alignment
K173890 · JWH
Medacta International S.A.
Orthopedic · 245d
Cleared Apr 19, 2018
MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments
K173472 · PQC
Medacta International S.A.
Orthopedic · 161d
Cleared Apr 05, 2018
Medacta Shoulder System Short Humeral Diaphysis
K180089 · PHX
Medacta International S.A.
Orthopedic · 83d
Cleared Mar 27, 2018
Mpact® 3D Metal™ Implants and Augments 3D Metal™
K171966 · LPH
Medacta International S.A.
Orthopedic · 270d
Cleared Mar 14, 2018
AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared
K173794 · LZO
Medacta International S.A.
Orthopedic · 90d
Cleared Dec 13, 2017
Medacta Shoulder System: Threaded Glenoid Baseplate
K171058 · PHX
Medacta International S.A.
Orthopedic · 247d
Cleared Dec 07, 2017
MasterLoc Stem: Lateralized Plus
K173267 · LZO
Medacta International S.A.
Orthopedic · 57d
Cleared Nov 29, 2017
M-Vizion Femoral Revision System
K170690 · LZO
Medacta International S.A.
Orthopedic · 267d
Cleared Nov 01, 2017
GMK Hinge, GMK Revision
K172347 · KRO
Medacta International S.A.
Orthopedic · 90d
Cleared Oct 23, 2017
M-ARS ACL: Anatomic Ribbon Surgery System
K171640 · MBI
Medacta International S.A.
Orthopedic · 143d
Cleared Oct 20, 2017
MyKnee PPS-Pin Positioners
K170106 · JWH
Medacta International S.A.
Orthopedic · 281d
Cleared Oct 05, 2017
Medacta Shoulder System
K170452 · PHX
Medacta International S.A.
Orthopedic · 232d
Cleared Sep 18, 2017
Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers
K172587 · ODP
Medacta International S.A.
Orthopedic · 21d
Cleared Aug 18, 2017
3DMetal Tibial Cones
K170149 · JWH
Medacta International S.A.
Orthopedic · 213d
Cleared Aug 16, 2017
Medacta Anatomic Shoulder Prosthesis
K170910 · KWS
Medacta International S.A.
Orthopedic · 141d
Cleared Aug 08, 2017
MiniMAX
K170845 · LZO
Medacta International S.A.
Orthopedic · 140d
Cleared Aug 02, 2017
M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
K171595 · OUR
Medacta International S.A.
Orthopedic · 63d
Cleared Aug 01, 2017
M.U.S.T. Combined Set Screws
K171758 · NKB
Medacta International S.A.
Orthopedic · 48d
Cleared Aug 01, 2017
M.U.S.T. MINI Posterior Cervical Screws System
K171369 · NKG
Medacta International S.A.
Orthopedic · 83d
Cleared May 25, 2017
M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional...
K171170 · NKB
Medacta International S.A.
Orthopedic · 34d
Cleared Apr 14, 2017
GMK UNI
K161741 · HSX
Medacta International S.A.
Orthopedic · 294d
Cleared Mar 31, 2017
AMIStem-H Proximal Coating
K161635 · LZO
Medacta International S.A.
Orthopedic · 290d