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
8401–8424 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 27, 2010
OSTEOPHIL BETA-TCP
K102937 · MQV
Cytophil, Inc.
Orthopedic · 84d
Cleared Dec 23, 2010
TSRH SPINAL SYSTEM
K103049 · NKB
Medtronic Sofamor Danek
Orthopedic · 69d
Cleared Dec 22, 2010
MICROFUSE PUTTY AND MICROFUSE ST MIS
K102392 · MQV
Globus Medical, Inc.
Orthopedic · 121d
Cleared Dec 22, 2010
ANTERIOR APPROACH HIP SURGERY INSTRUMENTS
K102565 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 106d
Cleared Dec 22, 2010
T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREES
K102992 · HSB
Howmedica Osteonics Corp.
Orthopedic · 75d
Cleared Dec 22, 2010
ARTHREX UNIVERS II SHOULDER PROSTHESIS
K103466 · KWS
Arthrex, Inc.
Orthopedic · 28d
Cleared Dec 21, 2010
TARGON FN SYSTEM
K102057 · KTT
Aesculap Implant Systems, LLC
Orthopedic · 152d
Cleared Dec 21, 2010
MATRYX INTERFERENCE SCREW (5.0-6.5MM)
K102410 · HWC
Conmed Linvatec
Orthopedic · 119d
Cleared Dec 21, 2010
THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY
K102549 · LZJ
Ascension Orthopedics, Inc.
Orthopedic · 105d
Cleared Dec 21, 2010
HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS
K103223 · OIY
Encore Medical, L.P.
Orthopedic · 50d
Cleared Dec 20, 2010
SYNTHES ZERO-P
K093762 · OVE
Synthes Spine
Orthopedic · 378d
Cleared Dec 20, 2010
INERTIA PEDICLE SCREW SYSTEM
K101278 · MNH
Nexxt Spine, LLC
Orthopedic · 228d
Cleared Dec 20, 2010
ENDURO KNEE SYSTEM
K101815 · KRO
Aesculap Implant Systems
Orthopedic · 173d
Cleared Dec 20, 2010
RHEAD RADIAL HEAD EXTENDED STEMS
K102180 · JDB
Small Bone Innovations, Inc.
Orthopedic · 140d
Cleared Dec 20, 2010
TWISTCUT ENDOSORB SCREWS
K102777 · JDW
Merete Medical GmbH
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
Cleared Dec 17, 2010
SMARTO
K101563 · KIJ
Jeil Medical Corporation
Orthopedic · 196d
Cleared Dec 16, 2010
VU CPOD INTERVERTEBRAL BODU FUSION DEVICE
K101363 · ODP
Musculoskeletal Clinical Regulatory...
Orthopedic · 216d
Cleared Dec 16, 2010
EXPEDIUM SPINE SYSTEM
K102249 · NKB
Depuy Spine, A Johnson & Johnson Company
Orthopedic · 129d
Cleared Dec 16, 2010
CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE
K102323 · OVE
Theken Spine, LLC
Orthopedic · 121d
Cleared Dec 16, 2010
NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM
K103147 · MNI
Medyssey Co, Ltd.
Orthopedic · 52d
Cleared Dec 16, 2010
POSTERIOR LATERAL PLATES
K103408 · HRS
DePuy Orthopaedics, Inc.
Orthopedic · 27d
Cleared Dec 15, 2010
DEPUY GLOBAL UNITE SHOULDER SYSTEM
K101996 · PHX
Depuy(Ireland)
Orthopedic · 153d
Cleared Dec 15, 2010
CONTOURS LAPIDUS PLATING SYSTEM
K102201 · HRS
Orthofix, Inc.
Orthopedic · 133d