FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,766 results
7993–8016 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 07, 2011
OSTEOMED HAND FUSION SYSTEM
K111419 · HRS
Osteomed LP
Orthopedic · 140d
Cleared Oct 07, 2011
MECTACER BIOLOX(R) DELTA FEMORAL HEADS
K112115 · LZO
Medacta International
Orthopedic · 74d
Cleared Oct 07, 2011
FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS
K112756 · MQP
Globus Medical, Inc.
Orthopedic · 16d
Cleared Oct 07, 2011
ORTHOLOC(TM) BONE SCREWS
K112772 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 14d
Cleared Oct 06, 2011
EASYLOCK OSTEOSYSTEM
K111266 · HRS
TriMed, Inc.
Orthopedic · 155d
Cleared Oct 06, 2011
RANGE SPINAL SYSTEM (MESA AND DENALI)
K112037 · MNI
K2m, Inc.
Orthopedic · 80d
Cleared Oct 05, 2011
ZIMMER PERIARTICULAR SCREWS
K111447 · HWC
Zimmer, Inc.
Orthopedic · 134d
Cleared Oct 05, 2011
EXETER X3 RIMFIT ACETABULAR CUP
K111848 · JDI
Stryker Corp.
Orthopedic · 98d
Cleared Oct 04, 2011
SOVEREIGN SPINAL SYSTEM
K110063 · OVD
Medtronic Sofamor Danek, Inc.
Orthopedic · 267d
Cleared Oct 03, 2011
REVERSE SHOULDER PROSTHESIS MONOBLOCK HEMI ADAPTER
K111735 · PHX
Encore Medical, L.P.
Orthopedic · 104d
Cleared Sep 30, 2011
LDR SPINE ROI-A INTERBODY FUSION SYSTEM
K110327 · OVD
Ldr Spine USA
Orthopedic · 239d
Cleared Sep 30, 2011
TAPERLOC COMPLETE MICROPLASTY STEM
K110400 · KWA
Biomet Manufacturing Corp
Orthopedic · 231d
Cleared Sep 29, 2011
X12 STERILE REFLECTIVE MARKER SPHERE
K111443 · OLO
Pinsco Inc. Dba B & L Engineering
Orthopedic · 128d
Cleared Sep 29, 2011
CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
K111916 · HSX
Conformis, Inc.
Orthopedic · 85d
Cleared Sep 28, 2011
SPINEFRONTIER LUMBAR IBF SYSTEM
K111553 · MAX
Spinefrontier, Inc.
Orthopedic · 117d
Cleared Sep 28, 2011
PIONEER CROSSFUSE II IBF/VBR SYSTEM
K112496 · MAX
Pioneer Surgical Technology, Inc.
Orthopedic · 30d
Cleared Sep 28, 2011
ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS
K112556 · MEH
Howmedica Osteonics Corp.
Orthopedic · 26d
Cleared Sep 27, 2011
EXETER HIP STEM
K110290 · JDI
Howmedica Osteonics Corp.
Orthopedic · 238d
Cleared Sep 27, 2011
META-LOCK SUTURE ANCHOR SYSTEM
K110800 · MBI
Tarsus Medical, Inc.
Orthopedic · 189d
Cleared Sep 27, 2011
CD HORIZON(R) SPINAL SYSTEM
K112555 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 25d
Cleared Sep 26, 2011
PASS LP SPINAL SYSTEM
K110497 · MNH
Medicrea International
Orthopedic · 216d
Cleared Sep 26, 2011
INQU PASTE MIX
K111838 · MQV
Isto Technologies, Inc.
Orthopedic · 89d
Cleared Sep 26, 2011
SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE
K111880 · MAX
Spineology, Inc.
Orthopedic · 87d
Cleared Sep 23, 2011
UNITED 36MM CERAMIC FEMORAL HEAD, DELTA
K112463 · LZO
United Orthopedic Corporation
Orthopedic · 28d