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
13849–13872 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 04, 1997
SMC FEMORAL HIP COMPONENT
K971681 · JDI
Signal Medical Corp.
Orthopedic · 212d
Cleared Dec 04, 1997
REACH FEMORAL HIP COMPONENT
K971824 · LPH
Biomet, Inc.
Orthopedic · 202d
Cleared Dec 02, 1997
FOUNDATION POROUS HIP STEM
K973302 · LPH
Encore Orthopedics, Inc.
Orthopedic · 90d
Cleared Dec 01, 1997
ACL CLIP-IN
K973323 · MBI
Innovasive Devices, Inc.
Orthopedic · 88d
Cleared Nov 24, 1997
NEXGEN COMPLETE KNEE SOLUTION CONVEX INSET PATELLA COMPONENT
K972270 · JWH
Zimmer, Inc.
Orthopedic · 166d
Cleared Nov 24, 1997
WHITESIDE BIOMECHANICS, INC. CERAMIC UNIPOLAR FEMORAL HEAD
K973261 · LZO
Whiteside Biomechanics, Inc.
Orthopedic · 87d
Cleared Nov 24, 1997
EXTEND HIP STEM
K973296 · JDI
Wrightmedicaltechnologyinc
Orthopedic · 83d
Cleared Nov 21, 1997
GREATBATCH SCIENTIFIC MR COMPATIBLE ARTHROSCOPES AND SMALL JOINT ARTHROSCOPES
K971781 · HRX
Wilson Greatbatch Technologies, Inc.
Orthopedic · 191d
Cleared Nov 21, 1997
ACETABULAR SHELLS WITH MESH INGROWTH SURFACE
K973163 · LPH
Howmedica Corp.
Orthopedic · 88d
Cleared Nov 20, 1997
ORTHOPEDIC SCREW SYSTEM
K972217 · HWC
Ferguson Medical
Orthopedic · 161d
Cleared Nov 20, 1997
ORTHOPEDIC PLATE SYSTEM
K972219 · HRS
Ferguson Medical
Orthopedic · 161d
Cleared Nov 20, 1997
HOWMEDICA TOTAL STABILIZER KNEE COMPONENTS
K973164 · JWH
Howmedica Corp.
Orthopedic · 87d
Cleared Nov 20, 1997
THE CORIFIX DYNAMIC HIP SCREW SYSTEM
K973231 · KTT
Corin USA
Orthopedic · 85d
Cleared Nov 20, 1997
SYNTHES PROXIMAL FEMORAL NAIL(PFN) SYSTEM MODIFICATION
K973240 · HTY
Synthes (Usa)
Orthopedic · 84d
Cleared Nov 20, 1997
S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD
K973307 · LZO
Johnson & Johnson Professionals, Inc.
Orthopedic · 78d
Cleared Nov 20, 1997
HOFFMANN II COMPACT PERIARTICULAR CLAMP
K973321 · KTT
Howmedica, Inc.
Orthopedic · 77d
Cleared Nov 18, 1997
INTERAX TOTAL KNEE SYSTEM
K973121 · JWH
Howmedica Corp.
Orthopedic · 90d
Cleared Nov 14, 1997
MOST HEX INTRAMEDULLARY (I/M) STEM
K973087 · LZO
Sulzer Orthopedics, Inc.
Orthopedic · 88d
Cleared Nov 13, 1997
PLUS EPF ACETABULAR CUP
K972931 · LWJ
Hhl Consulting
Orthopedic · 97d
Cleared Nov 13, 1997
PLUS-FIT ACETABULAR CUP
K973077 · LWJ
Plus Orthopedics
Orthopedic · 87d
Cleared Nov 12, 1997
ODI COMPRESSION HIP SCREW SYSTEM
K971993 · KTT
Orthopaedic Designs, Inc.
Orthopedic · 167d
Cleared Nov 12, 1997
DEPUY DURALOC ACETABULAR CUP SYSTEM
K972596 · LPH
Depuy, Inc.
Orthopedic · 124d
Cleared Nov 12, 1997
BONE GRAFT HARVESTER
K973560 · HWE
Ds Mfg., Inc.
Orthopedic · 54d
Cleared Nov 10, 1997
FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE
K965228 · MAI
United States Surgical, A Division of...
Orthopedic · 314d