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
6577–6600 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 21, 2014
ELIBRA SOFT-TISSUE FORCE SENSOR
K132104 · ONN
Kamm & Associates
Orthopedic · 256d
Cleared Mar 21, 2014
RANGE, SPINAL SYSTEM, EVEREST SPINAL SYSTEM
K133944 · NKB
K2m, Inc.
Orthopedic · 88d
Cleared Mar 20, 2014
CAMBER SPINE COVERIS CERVICAL CAGE
K133529 · ODP
Camber Spine
Orthopedic · 125d
Cleared Mar 20, 2014
TYBER MEDICAL TRAUMA SCREW
K133842 · HWC
Tyber Medical, LLC
Orthopedic · 92d
Cleared Mar 20, 2014
CAMBER SPINE DIAGON OBLIQUE CAGE
K134038 · MAX
Camber Spine
Orthopedic · 79d
Cleared Mar 19, 2014
METALLIC INTRAMEDULLARY NAIL SYSTEM
K132078 · HSB
Tianjin Walkman Biomaterial Co., Ltd.
Orthopedic · 257d
Cleared Mar 19, 2014
STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM
K133374 · KWP
Pioneer Surgical Technology, Inc....
Orthopedic · 138d
Cleared Mar 19, 2014
SPEED XL
K133780 · JDR
Biomedical Ent., Inc.
Orthopedic · 97d
Cleared Mar 14, 2014
BG MORSELS
K132805 · MQV
Prosidyan, Inc.
Orthopedic · 189d
Cleared Mar 14, 2014
STERISPINE LC CAGE
K133893 · MAX
Safe Orthopaedics
Orthopedic · 84d
Cleared Mar 13, 2014
ULTRACONGRUENT INSERT
K132752 · JWH
United Orthopedic Corporation
Orthopedic · 191d
Cleared Mar 13, 2014
CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM
K133205 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 146d
Cleared Mar 13, 2014
ARSENAL SPINAL FIXATION SYSTEM
K133221 · NKB
Alphatec Spine, Inc.
Orthopedic · 146d
Cleared Mar 13, 2014
OMNI ARC MONOBLOCK HIP STEM
K133381 · LZO
Omnilife Science
Orthopedic · 129d
Cleared Mar 13, 2014
KLASSIC HD HIP SYSTEM, OFFSET FEMORAL STEM, NON-POROUS / POROUS
K133832 · LPH
Total Joint Orthopedics, Inc.
Orthopedic · 86d
Cleared Mar 13, 2014
EMERGE MEDICAL DISTAL RADIUS SET
K140107 · HRS
Emerge Medical
Orthopedic · 57d
Cleared Mar 13, 2014
CD HORIZON SPINAL SYSTEM
K140276 · OSH
Medtronic Sofamor Danek
Orthopedic · 38d
Cleared Mar 12, 2014
POLARIS SPINAL SYSTEM
K133746 · NKB
Biomet Spine (Aka Ebi, LLC)
Orthopedic · 93d
Cleared Mar 12, 2014
EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM
K140098 · HRS
Emerge Medical
Orthopedic · 57d
Cleared Mar 12, 2014
EMERGE MEDICAL PERIARTICULAR AND LOCKING LARGE FRAGMENT SYSTEM
K140119 · HRS
Emerge Medical
Orthopedic · 55d
Cleared Mar 11, 2014
REVERE STABILIZATION SYSTEM
K133350 · NKB
Globus Medical, Inc.
Orthopedic · 132d
Cleared Mar 11, 2014
OVATION TRIBUTE HIP STEM
K133386 · LPH
Ortho Development Corp.
Orthopedic · 126d
Cleared Mar 10, 2014
DEPUY PINNACLE ALTRX ACETABULAR LINERS
K132959 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 171d
Cleared Mar 10, 2014
VAN HIP FRACTURE SYSTEM
K133104 · HSB
Epix Orthopaedic, Corp.
Orthopedic · 161d