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
12985–13008 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 04, 2000
TRIDENT ACETABULAR SHELLS: PS-HA
K001448 · MEH
Howmedica Osteonics Corp.
Orthopedic · 87d
Cleared Aug 04, 2000
TRIDENT ACETABULAR SHELLS: PS
K001449 · LZO
Howmedica Osteonics Corp.
Orthopedic · 87d
Cleared Aug 04, 2000
E-Z LINK CROSS CONNECTOR
K001470 · KWP
Depuyacromed
Orthopedic · 85d
Cleared Aug 04, 2000
BAUMER FEMORAL HEAD
K001571 · JDI
Baumer, S.A
Orthopedic · 74d
Cleared Aug 04, 2000
STRYKER TRAUMA PELVIC SET
K001614 · KTW
Howmedica Osteonics Corp.
Orthopedic · 71d
Cleared Aug 04, 2000
STIMULAN -CALCIUM SULFATE BONE VOID FILTER
K001724 · MQV
Biocomposites, Ltd.
Orthopedic · 59d
Cleared Aug 04, 2000
ARTHREX CHONDRAL DART, MODEL AR-4005B-18
K991971 · HTY
Arthrex, Inc.
Orthopedic · 420d
Cleared Aug 04, 2000
STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEM
K993166 · HWC
Stryker Endoscopy
Orthopedic · 317d
Cleared Jul 28, 2000
BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736
K001378 · MAI
Bionx Implants, Inc.
Orthopedic · 88d
Cleared Jul 28, 2000
SYNTHES BIORESORBABLE SUTURE ANCHOR
K994161 · MAI
Synthes (Usa)
Orthopedic · 232d
Cleared Jul 27, 2000
E-Z LINK CROSS CONNECTOR
K001372 · KWP
Depuyacromed
Orthopedic · 87d
Cleared Jul 27, 2000
PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT
K001374 · KRR
Biomet Manufacturing, Inc.
Orthopedic · 87d
Cleared Jul 27, 2000
HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS
K001385 · KWI
Howmedica Osteonics Corp.
Orthopedic · 86d
Cleared Jul 27, 2000
SOLAR SHOULDER OFFSET HUMERAL HEAD
K001419 · HSD
Howmedica Osteonics Corp.
Orthopedic · 83d
Cleared Jul 27, 2000
INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS
K001536 · KWA
Sulzer Orthopedics, Inc.
Orthopedic · 71d
Cleared Jul 27, 2000
MODIFICATION TO PROVIDENT HIP SYSTEM
K001745 · LWJ
Stelkast Company
Orthopedic · 49d
Cleared Jul 27, 2000
NEW BIO-MOORE ENDO HEAD, TAPER ADAPTER
K002106 · JDI
Biomet, Inc.
Orthopedic · 15d
Cleared Jul 26, 2000
STACKABLE CAGE SYSTEM
K001340 · MQP
Depuyacromed
Orthopedic · 90d
Cleared Jul 26, 2000
PATIENT MATCHED TITANIUM ALLOY TROCHLEA
K001350 · KRR
Biomet, Inc.
Orthopedic · 89d
Cleared Jul 26, 2000
TRI-LOCK HIP STEM
K001982 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 27d
Cleared Jul 25, 2000
NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR SCREW
K001323 · MRW
Nuvasive, Inc.
Orthopedic · 90d
Cleared Jul 25, 2000
SL-PLUS AND SLR-PLUS STEMS
K001942 · LWJ
Plus Orthopedics
Orthopedic · 29d
Cleared Jul 25, 2000
MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT
K001957 · KRO
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Jul 25, 2000
COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES
K001989 · JDC
Zimmer, Inc.
Orthopedic · 26d