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
9721–9744 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 13, 2008
ORIA NATURA SPACER
K073669 · MAX
Choicespine, LP
Orthopedic · 49d
Cleared Feb 13, 2008
ARTHREX COMPRESSION STAPLE
K080111 · JDR
Arthrex, Inc.
Orthopedic · 28d
Cleared Feb 11, 2008
SYNTHES ZERO-P
K072981 · OVE
Synthes Spine Co.Lp
Orthopedic · 111d
Cleared Feb 11, 2008
ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM
K073510 · NKB
Endius, Inc.
Orthopedic · 60d
Cleared Feb 08, 2008
DYNESYS TOP-LOADING SPINAL SYSTEM
K073347 · NQP
Zimmer Spine, Inc.
Orthopedic · 71d
Cleared Feb 07, 2008
SANATMETAL NAILS AND PINS
K070761 · HSB
Sanatmetal Mfr. of...
Orthopedic · 324d
Cleared Feb 07, 2008
CIMPLICITY SPINAL SYSTEM
K073320 · ODP
Spine Smith Partners L.P.
Orthopedic · 73d
Cleared Feb 07, 2008
SIDEKICK RAIL FIXATOR
K080071 · KTT
Wrightmedicaltechnologyinc
Orthopedic · 27d
Cleared Feb 06, 2008
DYNASTY CERAMIC FEMORAL HEAD
K072656 · LZO
Wrightmedicaltechnologyinc
Orthopedic · 139d
Cleared Feb 04, 2008
TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT
K072857 · JDI
Medacta International S.A.
Orthopedic · 122d
Cleared Feb 04, 2008
ACCIN PEDICLE SCREW SYSTEM
K073531 · MNH
Accelerated Innovation, LLC
Orthopedic · 49d
Cleared Feb 01, 2008
BONALIVE GRANULES
K071199 · MQV
Vivoxid , Ltd.
Orthopedic · 277d
Cleared Jan 31, 2008
ACCIN ANTERIOR CERVICAL PLATE SYSTEM
K073530 · KWQ
Accelerated Innovation, LLC
Orthopedic · 45d
Cleared Jan 30, 2008
ARDIS SPACER
K073202 · MAX
Abbott Spine, Inc.
Orthopedic · 78d
Cleared Jan 30, 2008
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
K073267 · NKB
Endius, Inc.
Orthopedic · 71d
Cleared Jan 30, 2008
DEPUY ASR 300 ACETABULAR CUP SYSTEM
K073413 · KWA
DePuy Orthopaedics, Inc.
Orthopedic · 57d
Cleared Jan 29, 2008
SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS
K073135 · LXT
Synthes (Usa)
Orthopedic · 83d
Cleared Jan 29, 2008
NUVASIVE HELIX MINI ACP SYSTEM
K073275 · KWQ
Nuvasive, Inc.
Orthopedic · 69d
Cleared Jan 29, 2008
VALEO PEDICLE SCREW SPINAL SYSTEM
K073430 · NKB
Amedica Corp.
Orthopedic · 54d
Cleared Jan 29, 2008
DEPUY DELTA XTEND REVERSE SHOULDER HIGH MOBILITY CUP
K073676 · PHX
DePuy Orthopaedics, Inc.
Orthopedic · 32d
Cleared Jan 28, 2008
BUTREX BUTTRESS PLATING SYSTEM
K072943 · KWQ
X-Spine Systems, Inc.
Orthopedic · 103d
Cleared Jan 28, 2008
ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS
K073233 · HSH
Advanced Bio-Surfaces, Inc.
Orthopedic · 74d
Cleared Jan 28, 2008
QUANTUM-MIS CANNULATED SYSTEM
K080026 · MNI
Pioneer Surgical Technology
Orthopedic · 24d
Cleared Jan 28, 2008
MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM
K080075 · MNI
Elite Surgical Supplies (Pty), Ltd.
Orthopedic · 17d