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"
169–192 of 208
Search insights Median review: 93d Cleared: 100% Top manufacturer: Medacta International S.A. Lead specialty: Orthopedic
Cleared Aug 22, 2013
GMK FULL PE TIBIAL COMPONENTS
K131310 · JWH
Medacta International
Orthopedic · 107d
Cleared Aug 15, 2013
GMK HINGE
K130299 · KRO
Medacta International
Orthopedic · 189d
Cleared Jul 26, 2013
GMK REVISION EXTENSION
K123721 · JWH
Medacta International
Orthopedic · 234d
Cleared Jul 05, 2013
MECTALIF
K131671 · MAX
Medacta International
Orthopedic · 28d
Cleared May 17, 2013
MECTALIF ANTERIOR
K124034 · OVD
Medacta International
Orthopedic · 140d
Cleared Oct 19, 2012
VERSAFITCUP CC TRIO EXTENSION
K122911 · LZO
Medacta International
Orthopedic · 28d
Cleared Sep 28, 2012
MPACT EXTENSION
K122641 · LZO
Medacta International
Orthopedic · 30d
Cleared Sep 28, 2012
GMK NARROW
K122232 · JWH
Medacta International
Orthopedic · 64d
Cleared Jul 20, 2012
GMK SPHERE
K121416 · JWH
Medacta International
Orthopedic · 70d
Cleared Jul 18, 2012
M.U.S.T PEDICLE SCREW SYSTEM
K121115 · KWP
Medacta International
Orthopedic · 97d
Cleared Jun 08, 2012
AMISTEM AND QUADRA - LINE EXTENSION
K121011 · LZO
Medacta International
Orthopedic · 66d
Cleared Jun 08, 2012
GMK - LINE EXTENSION
K120790 · JWH
Medacta International
Orthopedic · 85d
Cleared Apr 18, 2012
VERSAFITCUP CC TRIO-ADDITIONAL LINERS
K120531 · LZO
Medacta International
Orthopedic · 56d
Cleared Feb 28, 2012
MECTALIF TRANSFORAMINAL
K120024 · MAX
Medacta International S.A.
Orthopedic · 56d
Cleared Jan 27, 2012
GMK RESUFACING PATELLA SIZE 4
K113571 · JWH
Medacta International
Orthopedic · 56d
Cleared Dec 19, 2011
MECTA-C
K112862 · ODP
Medacta International
Orthopedic · 80d
Cleared Oct 07, 2011
MECTACER BIOLOX(R) DELTA FEMORAL HEADS
K112115 · LZO
Medacta International
Orthopedic · 74d
Cleared Aug 16, 2011
ENDO HEAD
K111145 · LZY
Medacta International
Orthopedic · 116d
Cleared Jun 13, 2011
MECTALIF
K110927 · MAX
Medacta International
Orthopedic · 77d
Cleared May 27, 2011
GMK REVISION HYBRID LINERS
K111283 · JWH
Medacta International
Orthopedic · 21d
Cleared Mar 24, 2011
GMK REVISION KNEE SC LINERS
K103170 · JWH
Medacta International S.A.
Orthopedic · 148d
Cleared Mar 21, 2011
MPACT ACETABULAR SYSTEM
K103721 · LPH
Medacta International
Orthopedic · 90d
Cleared Feb 11, 2011
VERSAFITCUP CC TRIO
K103352 · LZO
Medacta International
Orthopedic · 87d
Cleared Dec 20, 2010
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK
K103189 · LZO
Medacta International S.A.
Orthopedic · 53d