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."
1–24 of 60
Search insights Median review: 78d Cleared: 100% Top manufacturer: Conformis, Inc. Lead specialty: Orthopedic
Cleared Sep 08, 2023
Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS)...
K232426 · MBH
Conformis, Inc.
Orthopedic · 28d
Cleared Jul 21, 2023
Identity Imprint Porous Total Knee Replacement System, Identity Imprint...
K223316 · MBH
Conformis, Inc.
Orthopedic · 266d
Cleared Jul 17, 2023
iTotal Identity Knee Replacement System
K230846 · JWH
Conformis, Inc.
Orthopedic · 111d
Cleared May 26, 2023
Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS
K231233 · JWH
Conformis, Inc.
Orthopedic · 28d
Cleared May 23, 2023
ACTERA™ hip system
K231178 · MEH
Conformis, Inc.
Orthopedic · 27d
Cleared Apr 27, 2023
Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with...
K230844 · JWH
Conformis, Inc.
Orthopedic · 30d
Cleared Aug 04, 2022
Actera™ hip system
K221104 · MEH
Conformis, Inc.
Orthopedic · 112d
Cleared Jul 26, 2022
Identity Imprint Knee Replacement System (including Identity Imprint...
K221404 · JWH
Conformis, Inc.
Orthopedic · 71d
Cleared May 10, 2022
Identity Imprint Knee Replacement System (including Identity Imprint...
K221059 · JWH
Conformis, Inc.
Orthopedic · 29d
Cleared Nov 10, 2021
Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity...
K213389 · JWH
Conformis, Inc.
Orthopedic · 26d
Cleared Sep 23, 2021
Identity Imprint Knee Replacement System (including Identity Imprint...
K212411 · JWH
Conformis, Inc.
Orthopedic · 51d
Cleared May 12, 2021
iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS)
K210809 · JWH
Conformis, Inc.
Orthopedic · 56d
Cleared May 06, 2021
Identity Imprint Knee Replacement System
K210191 · JWH
Conformis, Inc.
Orthopedic · 101d
Cleared Apr 19, 2021
Triathlon AS-1
K203421 · OOG
Conformis, Inc.
Orthopedic · 150d
Cleared Feb 17, 2021
iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal...
K210252 · JWH
Conformis, Inc.
Orthopedic · 19d
Cleared Dec 22, 2020
iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal...
K203447 · JWH
Conformis, Inc.
Orthopedic · 29d
Cleared Sep 24, 2020
Cordera Hip System
K202484 · LPH
Conformis, Inc.
Orthopedic · 24d
Cleared Jun 16, 2020
iTotal® Identity Posterior Stabilized Knee Replacement System
K201023 · JWH
Conformis, Inc.
Orthopedic · 57d
Cleared Mar 13, 2020
iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair...
K193105 · JWH
Conformis, Inc.
Orthopedic · 126d
Cleared Nov 06, 2019
Conformis Hip System
K192198 · LPH
Conformis, Inc.
Orthopedic · 85d
Cleared Aug 28, 2019
Conformis BeneFIT Hip System
K190904 · LPH
Conformis, Inc.
Orthopedic · 142d
Cleared Aug 08, 2019
iTotal Identity Cruciate Retaining Knee Replacement System
K190562 · JWH
Conformis, Inc.
Orthopedic · 156d
Cleared May 16, 2018
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System
K180906 · JWH
Conformis, Inc.
Orthopedic · 40d
Cleared Oct 25, 2017
iTotal Family Reusable Instrument Tray
K170226 · KCT
Conformis, Inc.
General Hospital · 273d