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

60 results for "Conformis, Inc."
25–48 of 60
Search insights Median review: 78d Cleared: 100% Top manufacturer: Conformis, Inc. Lead specialty: Orthopedic
Cleared Jun 14, 2017
iTotal® Hip Replacement System
K162719 · LPH
Conformis, Inc.
Orthopedic · 258d
Cleared Jul 15, 2016
ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal...
K161668 · JWH
Conformis, Inc.
Orthopedic · 29d
Cleared Jun 14, 2016
ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)
K161366 · JWH
Conformis, Inc.
Orthopedic · 28d
Cleared Mar 25, 2016
iTotal Cruciate Retaining (CR) Knee Replacement System
K153721 · JWH
Conformis, Inc.
Orthopedic · 88d
Cleared Mar 07, 2016
iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate...
K160025 · JWH
Conformis, Inc.
Orthopedic · 61d
Cleared Jan 07, 2016
ConforMIS iTotal Posterior Stabilized Knee Replacement System
K153217 · JWH
Conformis, Inc.
Orthopedic · 63d
Cleared Oct 21, 2015
iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate...
K152704 · JWH
Conformis, Inc.
Orthopedic · 30d
Cleared Dec 11, 2014
iTotal Posterior Stabilized (PS) Knee Replacement System
K142404 · JWH
Conformis, Inc.
Orthopedic · 106d
Cleared Nov 14, 2014
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR...
K142161 · JWH
Conformis, Inc.
Orthopedic · 100d
Cleared Jun 30, 2014
ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM
K140833 · JWH
Conformis, Inc.
Orthopedic · 89d
Cleared May 27, 2014
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K140423 · JWH
Conformis, Inc.
Orthopedic · 98d
Cleared Mar 28, 2014
ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM
K133560 · JWH
Conformis, Inc.
Orthopedic · 128d
Cleared Jan 09, 2014
ITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMS, IDUO...
K133256 · JWH
Conformis, Inc.
Orthopedic · 78d
Cleared Dec 05, 2013
IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
K132640 · HSX
Conformis, Inc.
Orthopedic · 104d
Cleared Jul 18, 2013
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K131467 · JWH
Conformis, Inc.
Orthopedic · 58d
Cleared May 24, 2013
ITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT SYSTEM
K131019 · JWH
Conformis, Inc.
Orthopedic · 42d
Cleared Jan 14, 2013
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K122870 · JWH
Conformis, Inc.
Orthopedic · 117d
Cleared Dec 20, 2012
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K122991 · JWH
Conformis, Inc.
Orthopedic · 85d
Cleared Sep 27, 2012
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K122033 · JWH
Conformis, Inc.
Orthopedic · 78d
Cleared Sep 06, 2012
CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
K121974 · HSX
Conformis, Inc.
Orthopedic · 63d
Cleared Apr 19, 2012
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K120316 · JWH
Conformis, Inc.
Orthopedic · 78d
Cleared Feb 15, 2012
CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K113378 · JWH
Conformis, Inc.
Orthopedic · 91d
Cleared Feb 03, 2012
CONFORMIS ITOTAL CR KNEE REPLACEMENT SYSTEM (KRS)
K120068 · JWH
Conformis, Inc.
Orthopedic · 25d
Cleared Dec 15, 2011
CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K112780 · JWH
Conformis, Inc.
Orthopedic · 80d