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
8281–8304 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 15, 2011
ALTUM ANTERIOR CERVICAL PLATE
K103505 · KWQ
Spinecraft, LLC
Orthopedic · 106d
Cleared Mar 15, 2011
DEPUY ATTUNE TOTAL KNEE SYSTEM
K103756 · OIY
DePuy Orthopaedics, Inc.
Orthopedic · 82d
Cleared Mar 14, 2011
STCC
K100698 · ODP
Cardinal Spine, LLC
Orthopedic · 368d
Cleared Mar 14, 2011
NEWFIX EXTERNAL FIXATION SYSTEM
K101338 · KTT
Technologia Y Diseno Industrial, S.A...
Orthopedic · 306d
Cleared Mar 14, 2011
TRANS1 AXIALIF PLUS
K102334 · KWQ
Trans1 Incorporated
Orthopedic · 209d
Cleared Mar 11, 2011
GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD
K103712 · HWC
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 81d
Cleared Mar 10, 2011
DEPUY CORAIL HIP SYSTEM, REVISION STEM
K093736 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 461d
Cleared Mar 10, 2011
NOVEL TAPERED HIP STEM
K103479 · MEH
Stryker Corp.
Orthopedic · 104d
Cleared Mar 09, 2011
TRINITY ACETABULAR SYSTEM
K103518 · LWJ
Corin USA
Orthopedic · 99d
Cleared Mar 07, 2011
SYMMETRIC TOTAL KNEE AGUMENTS
K100370 · JWH
Signal Medical Corp.
Orthopedic · 388d
Cleared Mar 07, 2011
QUANTUM SPINAL SYSTEM, QUANTUM MIS
K101790 · NKB
Pioneer Surgical Technology
Orthopedic · 252d
Cleared Mar 07, 2011
PALLA M SPINAL SYSTEM
K102574 · MNH
Korea Bone Bank Co., Ltd.
Orthopedic · 180d
Cleared Mar 07, 2011
ALEUTTIAN
K103169 · ODP
K2m, Inc.
Orthopedic · 131d
Cleared Mar 04, 2011
TRIO TRAUMA SPINAL SYSTEM
K103292 · NKB
Stryker Corporation
Orthopedic · 116d
Cleared Mar 04, 2011
CERAMIC FEMORAL HEAD
K103497 · MEH
United Orthopedic Corp.
Orthopedic · 95d
Cleared Mar 04, 2011
BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR
K110145 · MBI
Biomet, Inc.
Orthopedic · 45d
Cleared Mar 04, 2011
OLECRA INTRAMEDULLARY FIXATION SYSTEM
K110322 · HSB
Mylad Orthopedic Solutions
Orthopedic · 29d
Cleared Mar 04, 2011
4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM
K110354 · JDP
Synthes (Usa)
Orthopedic · 25d
Cleared Mar 03, 2011
RESTORATION ACETABULAR WEDGE AUGMENTS
K102019 · LPH
Howmedica Osteonics
Orthopedic · 227d
Cleared Mar 03, 2011
VANGUARD REMOVABLE MOLDED POLY TIBIA
K102580 · JWH
Biomet Manufacturing Corp
Orthopedic · 176d
Cleared Mar 03, 2011
ZENITH PEDICLE SYSTEM
K102636 · MNH
Apollo Spine, Inc.
Orthopedic · 171d
Cleared Mar 03, 2011
NUVASIVE TRAVERSE PLATE SYSTEM
K103750 · KWQ
Nuvasive, Inc.
Orthopedic · 70d
Cleared Mar 02, 2011
SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM
K103002 · HSB
Synthes (Usa)
Orthopedic · 145d
Cleared Mar 02, 2011
CONCORDE BULLET CAGE SYSTEM
K103488 · MAX
Johnson and Johnson
Orthopedic · 96d