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
12697–12720 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 12, 2001
CD HORIZON SPINAL SYSTEM
K011508 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Jun 12, 2001
T2 HUMERAL NAIL SYSTEM
K011529 · HSB
Howmedica Osteonics Corp.
Orthopedic · 26d
Cleared Jun 06, 2001
USS-LINE EXTENSION
K010108 · MNI
Synthes
Orthopedic · 145d
Cleared Jun 06, 2001
TBW
K010545 · NDL
Tri-Med, Inc.
Orthopedic · 103d
Cleared Jun 06, 2001
TRI-FIX SPINAL FIXATION SYSTEM
K010903 · MNI
Endius, Inc.
Orthopedic · 72d
Cleared Jun 06, 2001
TRI-FIX SPINAL FIXATION SYSTEM
K010922 · MNI
Endius, Inc.
Orthopedic · 71d
Cleared Jun 06, 2001
BONUS-ORTHOPEDIC BONE SCREW FIXATION SYSTEM
K011390 · MBI
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 30d
Cleared Jun 06, 2001
SYNERGY 4.0 MM, 4.5 MM VLS SCREWS
K011437 · MNI
Interpore Cross Intl.
Orthopedic · 27d
Cleared Jun 05, 2001
MODIFICATION TO TSRH SPINAL SYSTEM
K011029 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 61d
Cleared Jun 04, 2001
MODIFIED USS FRACTURE SYSTEM
K010658 · MNI
Synthes (Usa)
Orthopedic · 90d
Cleared May 31, 2001
BUTTERFLY PLATE FUNCTION SYSTEM
K010632 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 90d
Cleared May 30, 2001
SCAPHIX, STAPLE, FIXATION, BONE
K003033 · JDR
Avanta Orthopaedics, Inc.
Orthopedic · 244d
Cleared May 30, 2001
SYNTHES RESORABLE MESHES AND SHEETS
K003788 · HRS
Synthes (Usa)
Orthopedic · 173d
Cleared May 30, 2001
CONVERGENCE CERVICAL SPINAL SYSTEM
K010639 · KWQ
Spinal Innovations, LLC
Orthopedic · 86d
Cleared May 30, 2001
2.0/2.4 CANNULATED SCREW SYSTEM
K010783 · HWC
Osteomed Corp.
Orthopedic · 76d
Cleared May 30, 2001
PERC-D SPINEWAND
K010811 · HRX
Arthrocare Corp.
Orthopedic · 72d
Cleared May 29, 2001
SCS CLOSED SCREW
K003733 · MNH
Ortho Tec, LLC
Orthopedic · 176d
Cleared May 29, 2001
SYNTHES SYNEX SPACER SYSTEM
K003836 · MQP
Synthes
Orthopedic · 168d
Cleared May 29, 2001
DJ ORTHOPEDICS POST SCREW
K010594 · HWC
Dj Orthopedics, LLC
Orthopedic · 90d
Cleared May 25, 2001
MENISCUS ARROW SHEATH #CN1000A
K010554 · HWC
Bionx Implants, Inc.
Orthopedic · 88d
Cleared May 25, 2001
JAX GRANULES BONE VOID FILLER
K010557 · MQV
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared May 25, 2001
END-TO-END AND SIDE-BY-SIDE CONNECTORS
K010563 · MNI
Spinal Concepts, Inc.
Orthopedic · 88d
Cleared May 24, 2001
TC-PLUS POROUS FEMORAL COMPONENTS
K011258 · JWH
Plus Orthopedics
Orthopedic · 30d
Cleared May 24, 2001
TC-PLUS POROUS TIBIAL COMPONENTS
K011288 · JWH
Plus Orthopedics
Orthopedic · 27d