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
11593–11616 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 11, 2004
LINVATEC 10K IRRIGATION SYSTEM
K033573 · HRX
Linvatec Corp.
Orthopedic · 90d
Cleared Feb 11, 2004
BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER
K040034 · MNI
Blackstone Medical, Inc.
Orthopedic · 34d
Cleared Feb 06, 2004
VOLAR RADIUS PLATE WITH ANGULAR STABILITY
K033756 · HRS
I.T.S. Implantat-Technologie-Systeme...
Orthopedic · 67d
Cleared Feb 05, 2004
TRIMED RADIAL BULLET
K030877 · HRS
Tri-Med, Inc.
Orthopedic · 322d
Cleared Feb 05, 2004
DEPUY SIGMA TIBIAL INSERTS
K033272 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 118d
Cleared Feb 05, 2004
SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT
K033382 · LOD
DePuy Orthopaedics, Inc.
Orthopedic · 105d
Cleared Feb 05, 2004
SMARTSET GHV GENTAMICIN BONE CEMENT
K033563 · LOD
DePuy Orthopaedics, Inc.
Orthopedic · 85d
Cleared Feb 05, 2004
SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM
K033618 · HSB
Synthes (Usa)
Orthopedic · 79d
Cleared Feb 05, 2004
SYNTHES ANTERIOR CERVICAL COMPRESSION SYSTEM
K033844 · KWQ
Synthes (Usa)
Orthopedic · 56d
Cleared Feb 02, 2004
COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE
K033506 · KWS
Biomet, Inc.
Orthopedic · 89d
Cleared Jan 28, 2004
EVOLVE RADIAL PLATE
K033456 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Jan 28, 2004
SKY BONE EXPANDER SYSTEM
K034037 · HRX
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 30d
Cleared Jan 27, 2004
PLUS PIVOT LINK UNIVERSAL SYSTEM
K033508 · MNI
Spine Vision, Inc.
Orthopedic · 82d
Cleared Jan 27, 2004
SHIRAZ-JAVA SPINAL FIXATION SYSTEM
K033772 · MNI
Spine Next America
Orthopedic · 55d
Cleared Jan 22, 2004
POSTERIOR CABLE SCREW
K022908 · MNI
Pioneer Surgical Technology
Orthopedic · 506d
Cleared Jan 22, 2004
SPACER G TEMPORARY HIP PROSTHESIS
K031841 · KWL
Exactech, Inc.
Orthopedic · 220d
Cleared Jan 20, 2004
GII SPINAL FIXATION SYSTEM
K032604 · MNH
Co-Ligne AG
Orthopedic · 148d
Cleared Jan 20, 2004
MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM
K032641 · MEH
Portland Orthopaedics Pty. , Ltd.
Orthopedic · 146d
Cleared Jan 20, 2004
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
K033476 · KTT
Howmedica Osteonics Corp.
Orthopedic · 78d
Cleared Jan 16, 2004
ZIMMER UNICOMPARTMENTAL KNEE SYSTEM
K033363 · HSX
Zimmer, Inc.
Orthopedic · 87d
Cleared Jan 15, 2004
BIODHOC
K024185 · HTY
Future Medical Systems, SA
Orthopedic · 392d
Cleared Jan 15, 2004
SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED)
K032108 · MBH
Aesculap, Inc.
Orthopedic · 191d
Cleared Jan 15, 2004
TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT
K032891 · HRX
Trans1, Inc.
Orthopedic · 120d
Cleared Jan 15, 2004
SCORPIO KNEE SYSTEM - TIBIAL INSERTS
K033342 · JWH
Howmedica Osteonics Corp.
Orthopedic · 90d