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
12001–12024 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 05, 2003
HA PMI FEMORAL HIP STEM
K030048 · LPH
Biomet Orthopedics, Inc.
Orthopedic · 30d
Cleared Feb 05, 2003
VERSYS BEADED FULLCOAT BOWED REVISION HIP PROSTHESIS
K030079 · LPH
Zimmer, Inc.
Orthopedic · 27d
Cleared Feb 05, 2003
SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS
K030103 · MNI
Depuyacromed
Orthopedic · 23d
Cleared Feb 05, 2003
DEPUY SUMMIT BASIC PRESS-FIT HIP STEM
K030122 · LWJ
DePuy Orthopaedics, Inc.
Orthopedic · 22d
Cleared Feb 03, 2003
REPROCESSED EXTERNAL FIXATION DEVICE
K023714 · KTT
Alliance Medical Corp.
Orthopedic · 90d
Cleared Feb 03, 2003
DURACON CS LIPPED EXTRA SMALL TIBIAL INSERT
K023724 · JWH
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Jan 30, 2003
BI-OSTETIC
K023703 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 87d
Cleared Jan 29, 2003
DEVEX MESH SYSTEM
K023835 · MQP
Depuyacromed
Orthopedic · 72d
Cleared Jan 28, 2003
BIOSORB RESORBABLE VOID FILLER
K021963 · MQV
Sciences ET Bio Materiaux (Sbm)
Orthopedic · 228d
Cleared Jan 28, 2003
SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM
K023802 · HRS
Synthes (Usa)
Orthopedic · 75d
Cleared Jan 28, 2003
PRECIMED HIP SCREW SYSTEM
K023851 · KTT
Precimed, Inc.
Orthopedic · 70d
Cleared Jan 28, 2003
ALUMINA V40 FEMORAL HEADS
K023901 · LZO
Howmedica Osteonics Corp.
Orthopedic · 67d
Cleared Jan 28, 2003
MONARCH SPINE SYSTEM
K024348 · MNH
Depuyacromed
Orthopedic · 29d
Cleared Jan 23, 2003
INTERPORE CROSS INTERNATIONAL ANTERIOR FIXATION DEVICE (AFD)
K022143 · MQP
Interpore Cross Intl.
Orthopedic · 205d
Cleared Jan 23, 2003
SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM
K023743 · KWY
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared Jan 23, 2003
MOSS MIAMI SPINAL SYSTEM PIN NUT
K023804 · KWP
Depuyacromed
Orthopedic · 70d
Cleared Jan 23, 2003
SYNTHES TOMOFIX OSTEOTOMY SYSTEM
K023941 · KTT
Synthes (Usa)
Orthopedic · 58d
Cleared Jan 23, 2003
OSTEO-CABLE SLEEVE
K024022 · HXN
Biomet, Inc.
Orthopedic · 49d
Cleared Jan 23, 2003
SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
K024326 · KWQ
Spinal Concepts, Inc.
Orthopedic · 28d
Cleared Jan 23, 2003
FREEDOM CONSTRAINED LINERS
K030047 · KWZ
Biomet, Inc.
Orthopedic · 17d
Cleared Jan 22, 2003
MODIFICATION TO EBI XFIX DFS SYSTEM METAPHYSEAL CORRECTION SYSTEM
K024248 · KTT
Ebi, L.P.
Orthopedic · 30d
Cleared Jan 17, 2003
NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE
K023528 · JWH
Centerplus Orthopedics, Inc.
Orthopedic · 88d
Cleared Jan 17, 2003
LESSER METATARSAL PHALANGEAL JOINT IMPLANT
K023531 · KWH
Nexa Orthopedics, Inc.
Orthopedic · 88d
Cleared Jan 17, 2003
MAXIM ACCEL KNEE SYSTEM
K023546 · JWH
Biomet, Inc.
Orthopedic · 87d