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
9673–9696 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 20, 2008
PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM
K080518 · NKB
Pioneer Surgical Technology
Orthopedic · 24d
Cleared Mar 19, 2008
SBI SR MTP TOE IMPLANT
K073635 · KWD
Small Bone Innovations, Inc.
Orthopedic · 84d
Cleared Mar 19, 2008
VARIAX DISTAL RADIUS TORX SCREWS
K080667 · HRS
Howmedica Osteonics Corp.
Orthopedic · 9d
Cleared Mar 18, 2008
HENKE SASS WOLF OF AMERICA ARTHROSCOPE
K080560 · HRX
Henke Sass Wolf of America, Inc.
Orthopedic · 19d
Cleared Mar 17, 2008
SPINAL SPHERE SYSTEM
K073274 · NVR
Life Spine
Orthopedic · 117d
Cleared Mar 14, 2008
SUB-TALAR LOK, MODEL 7-11 MM
K080280 · HWC
Instratek, Inc.
Orthopedic · 39d
Cleared Mar 13, 2008
BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES
K073567 · LZO
Zimmer GmbH
Orthopedic · 84d
Cleared Mar 13, 2008
BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM
K080394 · KWP
Blackstone Medical, Inc.
Orthopedic · 29d
Cleared Mar 13, 2008
BLACKSTONE SFS PARALLEL ROD CONNECTORS
K080407 · MNI
Blackstone Medical, Inc.
Orthopedic · 28d
Cleared Mar 12, 2008
MICRO QA+ ANCHOR WITHT #3-0 ORTHOCORD SUTURE, MODEL 212843, MICROFIX AQ+...
K080352 · HWC
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 30d
Cleared Mar 11, 2008
GRAFTYS BCP
K073064 · MQV
Graftys
Orthopedic · 133d
Cleared Mar 11, 2008
TRANS1 FACET SCREW
K073515 · MRW
Trans1 Incorporated
Orthopedic · 88d
Cleared Mar 10, 2008
MERRIES K-PHATE BONE GRAFT SUBSTITUTE
K063157 · MQV
Merries International, Inc.
Orthopedic · 510d
Cleared Mar 10, 2008
MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION...
K080258 · NKB
Endius, Inc.
Orthopedic · 39d
Cleared Mar 10, 2008
KIMBA MINI
K080349 · MQP
Signus Medizintechnik GmbH
Orthopedic · 28d
Cleared Mar 07, 2008
ZIMMER POROLOCK MIS STEM
K071723 · KWA
Zimmer GmbH
Orthopedic · 256d
Cleared Mar 07, 2008
JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE
K072212 · KTT
Smith & Nephew, Inc.
Orthopedic · 211d
Cleared Mar 07, 2008
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM
K073286 · JWH
Zimmer, Inc.
Orthopedic · 107d
Cleared Mar 06, 2008
AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX
K073470 · MAX
Stryker Spine
Orthopedic · 87d
Cleared Mar 04, 2008
TWINFIX PK FP SUTURE ANCHOR
K073509 · HWC
Smith & Nephew, Inc.
Orthopedic · 82d
Cleared Mar 03, 2008
PLEXUR M
K073405 · MQV
Osteotech, Inc.
Orthopedic · 90d
Cleared Feb 29, 2008
ACCIN PATELLOFEMORAL SYSTEM
K073120 · KRR
Accelerated Innovation, LLC
Orthopedic · 116d
Cleared Feb 29, 2008
DC ULNAR SHORTENING SYSTEM
K073228 · HRS
Orthopro, LLC
Orthopedic · 106d
Cleared Feb 29, 2008
SYNTHES OLECRANON OSTEOTOMY NAILING SYSTEM
K073402 · HSB
Synthes (Usa)
Orthopedic · 87d