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
12241–12264 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 09, 2002
TSRH SPINAL SYSTEM
K021170 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 88d
Cleared Jul 09, 2002
PROVEN MODULAR POSTERIOR STABILIZED FEMORAL
K021908 · JWH
Stelkast Company
Orthopedic · 29d
Cleared Jul 03, 2002
SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05,...
K021919 · KWP
Ortho Tec, LLC
Orthopedic · 22d
Cleared Jul 02, 2002
STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX
K021346 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 64d
Cleared Jul 02, 2002
TRIDENT CROSSFIRE POLYUETHYLENE LINERS
K021911 · LPH
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Jul 01, 2002
VERTEBRAL SPACER
K011037 · MQP
Synthes (Usa)
Orthopedic · 452d
Cleared Jul 01, 2002
GREAT TOE IMPLANT
K021063 · KWD
Signal Medical Corp.
Orthopedic · 90d
Cleared Jul 01, 2002
MACROPORE OS TRAUMA
K021164 · HRS
Macropore Biosurgery, Inc.
Orthopedic · 81d
Cleared Jul 01, 2002
METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES)
K021349 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 63d
Cleared Jul 01, 2002
MODIFICATION TO SPIRAL RADIUS 90-D SST SYSTEM
K021825 · KWP
Unitedstates Surgical
Orthopedic · 27d
Cleared Jul 01, 2002
SMALL HAMMER TOE PIN
K021828 · HWC
Biomet, Inc.
Orthopedic · 27d
Cleared Jul 01, 2002
BIOFASTIN RC THREADED SUTURE ANCHOR
K021883 · HWC
Mitek Worldwide
Orthopedic · 24d
Cleared Jun 26, 2002
DUET SUTURE ANCHOR
K020056 · HWC
Bionx Implants, Ltd.
Orthopedic · 169d
Cleared Jun 26, 2002
THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K021684 · JEY
Bioplate, Inc.
Orthopedic · 35d
Cleared Jun 26, 2002
T2 FEMORAL NAIL
K021744 · HSB
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Jun 26, 2002
ENDIUS ATAVI SYSTEM
K021748 · HRX
Endius, Inc.
Orthopedic · 29d
Cleared Jun 26, 2002
CEMENTED FEMORAL HEAD RESURFING DEVICE
K021799 · KXA
Biomet Orthopedics, Inc.
Orthopedic · 26d
Cleared Jun 26, 2002
ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER
K021832 · HWC
Biomet, Inc.
Orthopedic · 22d
Cleared Jun 26, 2002
CROSSOVER CROSS CONNECTOR (ISOLA SPINAL SYSTEM)
K021879 · MNH
Depuyacromed
Orthopedic · 19d
Cleared Jun 26, 2002
CROSSOVER CROSS CONNECTOR (MOSS MIAMI SPINE SYSTEM)
K021880 · MNH
Depuyacromed
Orthopedic · 19d
Cleared Jun 25, 2002
TITANIUM CANNULATED INTERFERENCE SCREW
K021030 · HWC
Future Medical Systems, Inc.
Orthopedic · 88d
Cleared Jun 24, 2002
REPROCESSED EXTERNAL FIXATION DEVICE
K012623 · KTT
Alliance Medical Corp.
Orthopedic · 315d
Cleared Jun 24, 2002
REPROCESSED EXTERNAL FIXATION DEVICE
K012634 · KTW
Alliance Medical, Inc.
Orthopedic · 315d
Cleared Jun 24, 2002
REPROCESSED EBI EXTERNAL FIXATION DEVICES
K012645 · KTW
Alliance Medical Corp.
Orthopedic · 315d