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
7873–7896 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 15, 2011
CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K112780 · JWH
Conformis, Inc.
Orthopedic · 80d
Cleared Dec 15, 2011
CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK...
K112876 · MBI
Cayenne Medical, Inc.
Orthopedic · 76d
Cleared Dec 15, 2011
MSA HIP SYSTEM
K113107 · MEH
Global Manufacturing Technology
Orthopedic · 56d
Cleared Dec 15, 2011
ROG SUTURE ANCHOR
K113299 · MBI
Rog Sports Medicine, Inc.
Orthopedic · 37d
Cleared Dec 14, 2011
4-WEB ALIF SPINAL TRUSS SYSTEM (STS)
K112316 · MAX
4-Web, Inc.
Orthopedic · 125d
Cleared Dec 13, 2011
VBB SYSTEM
K110604 · NDN
Synthes
Orthopedic · 285d
Cleared Dec 13, 2011
STAXX(R) XD SYSTEM
K111418 · MQP
Spine Wave, Inc.
Orthopedic · 207d
Cleared Dec 13, 2011
HEADLESS COMPRESSION SCREW
K112672 · HWC
Skeletal Dynamics, LLC
Orthopedic · 90d
Cleared Dec 13, 2011
INTERFACE BONE VOID FILLER
K112857 · MQV
Biostructures, LLC
Orthopedic · 74d
Cleared Dec 13, 2011
COUGAR SYSTEM
K113348 · MAX
Johnson & Johnson
Orthopedic · 29d
Cleared Dec 12, 2011
XINGTM SPINE SYSTEM
K111995 · MNH
Implanova Co., Ltd.
Orthopedic · 152d
Cleared Dec 12, 2011
SYNTHES ZERO-P
K112459 · OVE
Synthes Spine Co.Lp
Orthopedic · 108d
Cleared Dec 12, 2011
OSTEOSPRING FOOTJACK SUBTALAR IMPLANT SYSTEM
K112658 · HWC
Osteospring Medical, Inc.
Orthopedic · 90d
Cleared Dec 12, 2011
ARROW-LOK DIGITAL SYSTEM
K112675 · HTY
Arrowhead Medical Device...
Orthopedic · 89d
Cleared Dec 12, 2011
SPACER-S
K112983 · HSD
Tecres S.P.A.
Orthopedic · 67d
Cleared Dec 12, 2011
ORTHOLOC 3DSI LOCKING SCREWS
K113339 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 28d
Cleared Dec 12, 2011
ACCULIF TL CAGE
K113465 · MAX
Coalign Innovations, Inc.
Orthopedic · 20d
Cleared Dec 09, 2011
GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEM
K111132 · KWQ
Genesys Spine
Orthopedic · 231d
Cleared Dec 09, 2011
SI-LOK SACROILIAC JOINT FIXATION SYSTEM
K112028 · HWC
Globus Medical, Inc.
Orthopedic · 147d
Cleared Dec 09, 2011
RENOVIS CANNULATED SCREW SYSTEM
K113084 · HWC
Renovis Surgical Technologies, LLC
Orthopedic · 52d
Cleared Dec 09, 2011
OSLEOBRIDGE IDSF SPACER CONECTOR
K113303 · HSB
Merete Medical GmbH
Orthopedic · 30d
Cleared Dec 09, 2011
EVOLUTION MP ADAPTIVE CS INSERT
K113325 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 29d
Cleared Dec 08, 2011
SHIELD KYPHOPLASTY SYSTEM
K093477 · NDN
Soteira, Inc.
Orthopedic · 759d
Cleared Dec 08, 2011
VARILIFT CERVICAL INTERBODY FUSION SYSTEM
K111123 · ODP
Wenzel Spine
Orthopedic · 231d