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
12193–12216 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 12, 2002
MAGLY 6.5MM CANNULATED SCREWS
K021662 · HWC
Magly Orthopedics, LLC
Orthopedic · 84d
Cleared Aug 12, 2002
EBI DYNAFIX VS OSTEOTOMY SYSTEM
K021749 · NDF
Ebi, L.P.
Orthopedic · 76d
Cleared Aug 12, 2002
CADENCE CEMENT RESTRICTOR
K022218 · JDK
Spinal Concepts, Inc.
Orthopedic · 34d
Cleared Aug 12, 2002
EBI XFIX DFS SYSTEM
K022319 · KTT
Ebi, L.P.
Orthopedic · 26d
Cleared Aug 12, 2002
EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K022419 · KWQ
Ebi, L.P.
Orthopedic · 19d
Cleared Aug 09, 2002
SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW
K021556 · HWC
Synthes (Usa)
Orthopedic · 88d
Cleared Aug 09, 2002
NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE
K021578 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 87d
Cleared Aug 09, 2002
MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM
K021579 · HWC
Magly Orthopedics, LLC
Orthopedic · 87d
Cleared Aug 06, 2002
SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X
K022065 · JEC
Sintea Biotech, Inc.
Orthopedic · 42d
Cleared Aug 06, 2002
BLACKSTONE SPINAL FIXATION SYSTEM SPACER
K022399 · KWQ
Blackstone Medical, Inc.
Orthopedic · 14d
Cleared Aug 01, 2002
PLUS PIVOT LINK UNIVERSAL SYSTEM
K021507 · KWP
Spine Vision, Inc.
Orthopedic · 84d
Cleared Aug 01, 2002
UNI-T UNI-THREAD SPINAL SYSTEM
K021510 · MNI
Spine Vision, Inc.
Orthopedic · 84d
Cleared Aug 01, 2002
CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM
K021549 · KXA
Std Mfg., Inc.
Orthopedic · 80d
Cleared Aug 01, 2002
XIA SPINAL SYSTEM
K022160 · MNI
Howmedica Osteonics
Orthopedic · 29d
Cleared Jul 30, 2002
EPOCH HIP PROSTHESIS, MODEL 4075 SERIES
K014070 · LPH
Zimmer, Inc.
Orthopedic · 232d
Cleared Jul 29, 2002
WISORB MALLEOLAR SCREW
K020222 · HWC
Cambridge Scientific, Inc.
Orthopedic · 188d
Cleared Jul 29, 2002
ENDIUS TITLE SPINAL FIXATION SYSTEM
K021881 · MNH
Endius, Inc.
Orthopedic · 52d
Cleared Jul 25, 2002
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K021061 · KWP
Medtronic Sofamor Danek
Orthopedic · 114d
Cleared Jul 25, 2002
NOVABONE-RESORBABLE BONE GRAFT SUBSTITUTE
K021336 · MQV
Novabone Products, LLC
Orthopedic · 90d
Cleared Jul 25, 2002
36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)
K022077 · JDI
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Jul 25, 2002
PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING
K022094 · JDI
Biomet, Inc.
Orthopedic · 28d
Cleared Jul 25, 2002
VECTOR MEDICAL, INC., VECTOR TARGETING SYSTEM
K022225 · HSB
Vector Medical, Inc.
Orthopedic · 15d
Cleared Jul 25, 2002
MODOFOCATION TO SYNTHES ANKLE ARTHRODESIS PLATES
K022255 · HRS
Synthes (Usa)
Orthopedic · 13d
Cleared Jul 24, 2002
SYNTHES IN-SITU BENDER/CUTTER
K021458 · HRS
Synthes (Usa)
Orthopedic · 78d