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
10801–10824 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 07, 2005
ANTHOLOGY HIP STEM
K052792 · JDI
Smith & Nephew, Inc.
Orthopedic · 4d
Cleared Oct 06, 2005
DEPUY GLOBAL SHOULDER CROSSLINK GLENOID
K052472 · KWS
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared Oct 05, 2005
SCIENT'X CEMENT RESTRICTOR
K052367 · JDK
Scient'X
Orthopedic · 37d
Cleared Oct 04, 2005
POROUS COATED ACETABULAR COMPONENTS
K050124 · KWA
Biomet, Inc.
Orthopedic · 258d
Cleared Sep 29, 2005
LINEAGE HA ACETABULAR SHELLS
K043099 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 324d
Cleared Sep 29, 2005
RINGLOC BI-POLAR ACETABULAR COMPONENT
K051569 · JDI
Biomet, Inc.
Orthopedic · 107d
Cleared Sep 29, 2005
MERRIES UNI-OSTEO, MODEL CS30250-CS10102
K051698 · MQV
Merries International, Inc.
Orthopedic · 97d
Cleared Sep 29, 2005
COPELAND EAS HUMERAL RESURFACING HEADS
K051843 · HSD
Biomet, Inc.
Orthopedic · 84d
Cleared Sep 28, 2005
CERAMENT BONE VOID FILLER
K051951 · MQV
Bonesupport AB
Orthopedic · 72d
Cleared Sep 28, 2005
EXPEDIUM SPINE SYSTEM 5.5MM COMMERICALLY PURE TITANIUM SPINAL RODS
K052131 · KWP
Depuy Spine, Inc.
Orthopedic · 54d
Cleared Sep 28, 2005
LOW PROFILE PLATE AND SCREW SYSTEM
K052614 · HRS
Arthrex, Inc.
Orthopedic · 5d
Cleared Sep 27, 2005
E-POLY (VITAMIN E) ACETABULAR LINERS
K050327 · LPH
Biomet, Inc.
Orthopedic · 230d
Cleared Sep 27, 2005
ARTHREX TENODESIS FAMILY
K051726 · HWC
Arthrex, Inc.
Orthopedic · 91d
Cleared Sep 27, 2005
ACCOLADE RPS HIP STEM
K052542 · LZO
Stryker Orthopaedics
Orthopedic · 12d
Cleared Sep 26, 2005
ACCOLADE HFX FEMORAL STEM
K051741 · LZO
Stryker Orthopaedics
Orthopedic · 90d
Cleared Sep 26, 2005
TRANS1 FACET SCREWS
K051856 · MRW
Trans1 Incorporated
Orthopedic · 80d
Cleared Sep 23, 2005
ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS
K050637 · JDI
Ortho Development Corp.
Orthopedic · 196d
Cleared Sep 23, 2005
TRABECULAR METAL VERTEBRAL BODY REPLACEMENT
K051978 · MQP
Implex Corp.
Orthopedic · 64d
Cleared Sep 23, 2005
SYNTHES PANGEA SYSTEM
K052123 · KWP
Synthes (Usa)
Orthopedic · 49d
Cleared Sep 23, 2005
MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM
K052376 · KWP
Medtronic Sofamor Danek
Orthopedic · 24d
Cleared Sep 23, 2005
VERTEX RECONSTRUCTION SYSTEM
K052402 · KWP
Medtronic Sofamor Danek
Orthopedic · 22d
Cleared Sep 21, 2005
SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEM
K051678 · HSB
Synthes (Usa)
Orthopedic · 90d
Cleared Sep 21, 2005
SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM
K051697 · MNH
Medical Device Advisory Development...
Orthopedic · 90d
Cleared Sep 21, 2005
REPROCESSED EXTERNAL FIXATION DEVICE
K051957 · KTT
Sterilemed, Inc.
Orthopedic · 68d