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
8809–8832 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 16, 2010
SKELTEX ISV
K091234 · NDN
Skeltex Technologies, Inc.
Orthopedic · 295d
Cleared Feb 12, 2010
CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX
K100061 · KWQ
K2m, Inc.
Orthopedic · 32d
Cleared Feb 12, 2010
MODIFICATION TO CAPSURE PS SYSTEM
K100122 · MNH
Spine Wave, Inc.
Orthopedic · 28d
Cleared Feb 05, 2010
ORTHO SELECT BONE PLATES AND SCREW SYSTEM
K091493 · HRS
Ortho Select Implant Technology...
Orthopedic · 261d
Cleared Feb 05, 2010
ACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEM
K093567 · JWH
Anova Implant Solutions, LLC
Orthopedic · 79d
Cleared Feb 04, 2010
CORIN METAFIX FEMORAL STEM
K082525 · LZO
Corin USA
Orthopedic · 520d
Cleared Feb 04, 2010
SPINE360 ANTERIOR CERVICAL PLATE SYSTEM
K092531 · KWQ
Spine360
Orthopedic · 170d
Cleared Feb 04, 2010
ESL SPINAL SYSTEM
K092574 · MAX
Ebi, L.P.
Orthopedic · 167d
Cleared Feb 04, 2010
OMNISPAN MENISCAL REPAIR SYSTEM/0 DEGREE, MODEL 228140, RAPIDLOC A2 MENISCAL...
K092836 · MBI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 142d
Cleared Feb 04, 2010
VERTOS MEDICAL MILD DEVICE KIT
K093062 · HRX
X-Sten Corp.
Orthopedic · 127d
Cleared Feb 04, 2010
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS
K093846 · LZO
Zimmer, Inc.
Orthopedic · 51d
Cleared Feb 04, 2010
FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY
K100044 · NKB
Blackstone
Orthopedic · 27d
Cleared Feb 04, 2010
UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
K100070 · KWQ
Depuy Spine, Inc.
Orthopedic · 24d
Cleared Feb 02, 2010
ATLAS INTERVERTEBRAL BODY CAGE
K092774 · MAX
Spinal Edge, LLC
Orthopedic · 146d
Cleared Feb 02, 2010
DEPUY FRACTURE AND FUSION PLATING SYSTEM
K093474 · HRS
DePuy Orthopaedics, Inc.
Orthopedic · 88d
Cleared Feb 02, 2010
EVOLVE EPS ORTHOLOC
K100146 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 14d
Cleared Jan 28, 2010
VALEO SPACER SYSTEM
K091278 · MAX
Amedica Corp.
Orthopedic · 272d
Cleared Jan 28, 2010
VARIAX ELBOW SYSTEM PLATE LINE EXTENSION
K093433 · HRS
Howmedica Osteonics Corp.
Orthopedic · 85d
Cleared Jan 27, 2010
C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY...
K092540 · ODP
Rsb Spine, LLC
Orthopedic · 161d
Cleared Jan 26, 2010
COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS
K093363 · MBL
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Jan 25, 2010
ANY PLUS SPINAL FIXATION SYSTEM
K091717 · NKB
GS Medical Co., Ltd.
Orthopedic · 228d
Cleared Jan 22, 2010
PATIENT SPECIFIC ACETABULAR RECONSTRUCTION PROSTHESIS
K092098 · LPH
Smith & Nephew, Inc.
Orthopedic · 192d
Cleared Jan 22, 2010
ACP4 SPINAL IMPLANT SYSTEM
K092360 · KWQ
X-Spine Systems, Inc.
Orthopedic · 171d
Cleared Jan 22, 2010
MODIFIED: NEWDEAL HALLU PLATES
K093781 · HRS
Newdeal Sas
Orthopedic · 44d