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
11689–11712 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 05, 2003
VITOSS-FILLED CARTRIDGE
K032130 · MQV
Orthovita, Inc.
Orthopedic · 117d
Cleared Nov 05, 2003
VERSYS BEADED FULLCOAT CALCAR HIP PROSTHESIS
K033034 · LPH
Zimmer, Inc.
Orthopedic · 37d
Cleared Nov 05, 2003
SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM
K033071 · JDS
Synthes (Usa)
Orthopedic · 37d
Cleared Nov 05, 2003
WRISTJACK ORIF SYSTEM, WRISTJACK ORIF SYSTEM, NON-STERILE, MODELS CFD-347,...
K033112 · KTT
Hand Biomechanics Lab, Inc.
Orthopedic · 36d
Cleared Nov 05, 2003
HOFFMANN II PELVIC CLAMP
K033145 · LXT
Howmedica Osteonics Corp.
Orthopedic · 36d
Cleared Nov 05, 2003
SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES
K033158 · KTT
Synthes (Usa)
Orthopedic · 36d
Cleared Nov 05, 2003
LACTOSORB TIBIAL L-15 SCREW AND WASHER
K033233 · HWC
Biomet, Inc.
Orthopedic · 30d
Cleared Oct 31, 2003
CONSERVE PLUS SPIKED ACETABULAR SHELLS AND CONSERVE TOTAL 56MM FEMORAL HEAD
K031963 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 128d
Cleared Oct 31, 2003
PLUS PIVOT LINK UNIVERSAL SYSTEM
K032398 · MNI
Spine Vision, Inc.
Orthopedic · 88d
Cleared Oct 31, 2003
HEDROCEL VERTEBRAL BODY REPLACEMENT
K032527 · MQP
Implex Corp.
Orthopedic · 77d
Cleared Oct 30, 2003
POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.911, 8564.121/.851
K030082 · HRX
Richard Wolf Medical Instruments Corp.
Orthopedic · 294d
Cleared Oct 30, 2003
PROFUSION BONE VOID FILLER KIT
K031838 · MQV
Biogeneration
Orthopedic · 136d
Cleared Oct 30, 2003
GLOBAL PRESS-FIT STEM
K032385 · LPH
Global Medical Co.
Orthopedic · 87d
Cleared Oct 24, 2003
CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP
K032348 · LZO
Centerpulse Orthopedics, Inc.
Orthopedic · 86d
Cleared Oct 22, 2003
CONKLUSION PEDICLE SCREW SYSTEM
K031455 · MNI
Signus Medical, LLC
Orthopedic · 168d
Cleared Oct 22, 2003
INTER-OS LIMB LENGTHENER
K031875 · KTT
Inter-Os Technologies
Orthopedic · 127d
Cleared Oct 22, 2003
T2 NAILING SYSTEM
K032523 · HSB
Howmedica Osteonics Corp.
Orthopedic · 68d
Cleared Oct 22, 2003
TARAS THREADED FIXATION PIN
K032532 · JDW
Union Surgical, LLC
Orthopedic · 68d
Cleared Oct 22, 2003
SYNTHES 4.0MM TITANIUM (TI.) LOCKING SCREWS
K032559 · HRS
Synthes (Usa)
Orthopedic · 64d
Cleared Oct 22, 2003
STS SCREW
K032682 · HWC
Ortho-Pro, LLC
Orthopedic · 54d
Cleared Oct 22, 2003
ASCENSION MODULAR RADIAL HEAD
K032686 · KWI
Ascension Orthopedics, Inc.
Orthopedic · 54d
Cleared Oct 22, 2003
ZIMMER M/L TAPER HIP PROSTHESIS, 7711 SERIES
K032726 · LPH
Zimmer, Inc.
Orthopedic · 49d
Cleared Oct 21, 2003
ISO-ELASTIC CERCLAGE SYSTEM
K030256 · JDQ
Kinamed, Inc.
Orthopedic · 270d
Cleared Oct 15, 2003
SC TOTAL HIP SYSTEM
K031474 · JDI
Orthopedic Alliance, LLC
Orthopedic · 159d