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
13417–13440 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 26, 1999
VILEX CANNULATED BONE SCREW, DUVAL CANNULATED BONE SCREW, ORTHEX CANNULATED...
K991151 · HWC
Vilex, Inc.
Orthopedic · 20d
Cleared Apr 26, 1999
VILEX/DUVAL/ORTHEX CANNULATED BONE SCREW, MODELS P222-XX, S25-XX, P227-XX,...
K991197 · HWC
Vilex, Inc.
Orthopedic · 19d
Cleared Apr 23, 1999
EBI VUECATH ENDOSCOPIC SYSTEN
K990459 · HRX
Electro-Biology, Inc.
Orthopedic · 70d
Cleared Apr 14, 1999
HEADED BIO-ABSORBABLE CORKSCREW MODEL #AR-1921BU
K990361 · MAI
Arthrex, Inc.
Orthopedic · 68d
Cleared Apr 14, 1999
MODIFICATION OF: EBI SPINELINK SYSTEM
K990999 · MAI
Electro-Biology, Inc.
Orthopedic · 20d
Cleared Apr 13, 1999
MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15
K990845 · KWP
Advanced Spine Fixation Systems, Inc.
Orthopedic · 29d
Cleared Apr 08, 1999
OMEGA II MODULAR TOTAL HIP SYSTEM
K984227 · JDI
Osteoimplant Technology, Inc.
Orthopedic · 134d
Cleared Apr 01, 1999
OMNI-FIX, NAIL SYSTEM
K990307 · KTW
Turnkey Intergration USA, Inc.
Orthopedic · 59d
Cleared Apr 01, 1999
PERRY HUMERAL NAIL
K990322 · HSB
Pioneer Surgical Technology
Orthopedic · 58d
Cleared Mar 31, 1999
ULTIMAX TROCHANTERIC INTRAMEDULLARY ROD SYSTEM
K990436 · HSB
Biodynamic Technologies, Inc.
Orthopedic · 48d
Cleared Mar 30, 1999
TITANIUM VERSALOK
K990708 · KWP
Wrightmedicaltechnologyinc
Orthopedic · 26d
Cleared Mar 30, 1999
MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM
K990745 · MNI
Synthes Spine
Orthopedic · 22d
Cleared Mar 26, 1999
TRIFIX PEDICLE SPINAL SCREW ASSEMBLY
K990657 · MNH
Corin USA
Orthopedic · 25d
Cleared Mar 25, 1999
OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM
K982798 · KWQ
Osteonics Corp.
Orthopedic · 227d
Cleared Mar 23, 1999
ABLATOR ELECTRODE
K983652 · HRX
Linvatec Corp.
Orthopedic · 155d
Cleared Mar 23, 1999
SYNERGY D2 SPINAL IMPLANTS
K984578 · MNI
Interpore Cross Intl.
Orthopedic · 90d
Cleared Mar 23, 1999
LACTOSORB BONE PIN
K990291 · HTY
Biomet, Inc.
Orthopedic · 53d
Cleared Mar 23, 1999
DEPUY ACE SPIDER PLATE
K990392 · HRS
Depuy Ace Medical Co.
Orthopedic · 42d
Cleared Mar 22, 1999
ISOBAR SPINAL SYSTEM
K990118 · MNH
Scien'Tx USA, Inc.
Orthopedic · 68d
Cleared Mar 17, 1999
HINGED KNEE
K982160 · KRO
Encore Orthopedics, Inc.
Orthopedic · 271d
Cleared Mar 17, 1999
ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM
K990481 · HRS
Biodynamic Technologies, Inc.
Orthopedic · 29d
Cleared Mar 17, 1999
ULTIMAX CORTICAL BONE SCREWS
K990513 · HWC
Biodynamic Technologies, Inc.
Orthopedic · 27d
Cleared Mar 15, 1999
IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA
K983835 · JWH
Implex Corp.
Orthopedic · 136d
Cleared Mar 15, 1999
TIGRAN HIP PROSTHESIS
K984492 · LPH
Ponmed , Ltd.
Orthopedic · 88d