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
8689–8712 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 19, 2010
IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF
K083798 · MAX
Medicrea Technologies
Orthopedic · 513d
Cleared May 19, 2010
SUBFIX ARTHROEREISIS IMPLANT, MODELS SUT0065, SUT0080, SUT0090, SUT0100, SUT0115
K093820 · HWC
Memometal Technologies
Orthopedic · 156d
Cleared May 19, 2010
REGENT ANTERIOR CERVICAL PLATE
K101151 · KWQ
Custom Spine
Orthopedic · 26d
Cleared May 18, 2010
CARDO MEDICAL CERAMIC HIP SYSTEM
K100008 · LZO
Cardo Medical, Inc.
Orthopedic · 134d
Cleared May 18, 2010
TITAN TI SUTURE ANCHOR SYSTEM, MODELS 22-9055, 22-9055N, 22-9065, 22-9065N,...
K101184 · MBI
Arthrocare Corp.
Orthopedic · 20d
Cleared May 17, 2010
POLARIS SPINAL SYSTEM
K100220 · NKB
Ebi, L.P.
Orthopedic · 111d
Cleared May 17, 2010
ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEM
K100240 · HRS
OrthoPediatrics Corp.
Orthopedic · 110d
Cleared May 14, 2010
VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES
K100271 · HRS
Howmedica Osteonics Corp.
Orthopedic · 105d
Cleared May 14, 2010
COCR RODS
K100788 · NKB
Globus Medical, Inc.
Orthopedic · 53d
Cleared May 13, 2010
SYNTHES T-PAL SPACER
K100089 · MAX
Synthes Spine
Orthopedic · 121d
Cleared May 13, 2010
DIAMOND ANTERIOR CERVICAL PLATE SYSTEM
K100265 · KWQ
Amendia, Inc.
Orthopedic · 104d
Cleared May 13, 2010
LEGION POROUS + HA TIBIAL BASEPLATES
K100897 · MBH
Smith & Nephew, Inc.
Orthopedic · 43d
Cleared May 13, 2010
VARIAX ELBOW SYSTEM
K101056 · HRS
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared May 11, 2010
SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED...
K092190 · KTT
Synthes (Usa)
Orthopedic · 294d
Cleared May 11, 2010
SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATES
K092812 · HRS
Synthes (Usa)
Orthopedic · 239d
Cleared May 11, 2010
EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM
K093978 · HRS
Exactech, Inc.
Orthopedic · 138d
Cleared May 11, 2010
HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM
K100238 · HSB
DePuy Orthopaedics, Inc.
Orthopedic · 104d
Cleared May 07, 2010
SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM
K094002 · NKB
Spartek Medical, Inc.
Orthopedic · 130d
Cleared May 06, 2010
AEQUALIS REVERSED SHOULDER PROSTHESIS
K100142 · PHX
Tornier
Orthopedic · 107d
Cleared May 05, 2010
BIOLOX DELTA CERAMIC FEMORAL HEADS
K100412 · LZO
Smith & Nephew, Inc.
Orthopedic · 78d
Cleared May 04, 2010
PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES
K100325 · HWC
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared May 04, 2010
HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES
K100614 · KWQ
Blackstone Medical, Inc.
Orthopedic · 61d
Cleared Apr 30, 2010
TSRH SPINAL SYSTEM
K091797 · NKB
Medtronic Sofamor Danek
Orthopedic · 317d
Cleared Apr 30, 2010
RINGLOC + HYBRID ACETABULAR SYSTEM
K093235 · KWA
Biomet, Inc.
Orthopedic · 197d