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
8185–8208 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 23, 2011
TSRH SPINAL SYSTEM
K110676 · NKB
Medtronic Sofamor Danek
Orthopedic · 74d
Cleared May 20, 2011
INTERCONTINENTAL PLATE-SPACER
K103382 · OVD
Globus Medical, Inc.
Orthopedic · 183d
Cleared May 20, 2011
K2M COCR WIRE
K103797 · JDQ
K2m, Inc.
Orthopedic · 144d
Cleared May 19, 2011
ROG KNOTLESS SUTURE ANCHOR
K110230 · MBI
Rog Sports Medicine, Inc.
Orthopedic · 113d
Cleared May 19, 2011
ZENIUS SPINAL SYSTEM
K110283 · MNI
Medyssey Co, Ltd.
Orthopedic · 107d
Cleared May 19, 2011
STRYKER PATIENT SPECIFIC CUTTING GUIDE
K110533 · MBH
Stryker Corp.
Orthopedic · 84d
Cleared May 19, 2011
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM
K111039 · HRS
Zimmer, Inc.
Orthopedic · 35d
Cleared May 18, 2011
ROG SUTURE ANCHOR 5.5MM, 2.9MM
K110229 · MBI
Rog Sports Medicine, Inc.
Orthopedic · 112d
Cleared May 18, 2011
BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM
K110574 · HRS
Biomet Microfixation, Inc.
Orthopedic · 78d
Cleared May 17, 2011
DASH KNEE
K102251 · OLO
Brainlab AG
Orthopedic · 281d
Cleared May 17, 2011
EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD
K110706 · KWT
Exactech, Inc.
Orthopedic · 64d
Cleared May 17, 2011
STERILE STORM (R) OPERATING KIT
K111001 · HWC
Intelligent Orthopaedics, Ltd.
Orthopedic · 36d
Cleared May 16, 2011
SIGNATURE PLANNER / SIGNATURE GUIDES
K110415 · HRY
Materialise NV
Orthopedic · 91d
Cleared May 13, 2011
MAHE FIXATION PLATE AND SCREW SYSTEM
K102845 · HRS
Mahe Medical GmbH
Orthopedic · 226d
Cleared May 13, 2011
COUGAR LS LATERAL CAGE SYSTEM
K110454 · MAX
Johnson & Johnson
Orthopedic · 86d
Cleared May 12, 2011
SEASPINE SPACER SYSTEM
K102026 · MAX
Seaspine, Inc.
Orthopedic · 297d
Cleared May 12, 2011
STREAMLINE TL SPINAL SYSTEM
K110692 · NKB
Pioneer Surgical Technology, Inc.
Orthopedic · 62d
Cleared May 11, 2011
RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM
K110965 · KTT
Renovis Surgical Technologies, LLC
Orthopedic · 35d
Cleared May 10, 2011
GLADIATOR PLASMA CLASSIC HIP STEM
K110399 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 88d
Cleared May 05, 2011
HLS KNEETEC SYSTEM
K094013 · JWH
Tornier
Orthopedic · 492d
Cleared May 05, 2011
REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C
K103835 · KWS
Howmedica Osteonics Corp.
Orthopedic · 126d
Cleared May 05, 2011
ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM
K110963 · KWP
Globus Medical, Inc.
Orthopedic · 29d
Cleared May 05, 2011
ISSYS LP SPINAL FIXATION SYSTEM
K111099 · NKB
Custom Spine, Inc.
Orthopedic · 15d
Cleared May 04, 2011
ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM
K102324 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 260d