FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,850 results
13057–13080 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 18, 2000
XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY
K001653 · KWP
Howmedica Osteonics Corp.
Orthopedic · 80d
Cleared Aug 17, 2000
GROSS FEMORAL COMPONENT
K001580 · MEH
Biomet, Inc.
Orthopedic · 87d
Cleared Aug 17, 2000
SYNTHES SCALLOPED DISTAL TIBIA PLATE
K001793 · LXT
Synthes (Usa)
Orthopedic · 64d
Cleared Aug 17, 2000
STELKAST PROVEN KNEE SYSTEM
K002281 · JWH
Stelkast Company
Orthopedic · 24d
Cleared Aug 16, 2000
WMT MODULAR SHOULDER SYSTEM
K001706 · KWS
Wrightmedicaltechnologyinc
Orthopedic · 72d
Cleared Aug 16, 2000
SURGICAL DYNAMICS SPINAL RETRACTOR
K002008 · HRX
United States Surgical, A Division of...
Orthopedic · 44d
Cleared Aug 16, 2000
ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH...
K002141 · LWJ
Exactech, Inc.
Orthopedic · 30d
Cleared Aug 10, 2000
ULTIMA METAL-ON-METAL ACETABULAR CUP
K001523 · KWA
DePuy Orthopaedics, Inc.
Orthopedic · 86d
Cleared Aug 07, 2000
CONSENSUS KNEE SYSTEM
K001456 · JWH
Hayes Medical, Inc.
Orthopedic · 90d
Cleared Aug 07, 2000
THE IMPLEX HEDROCEL ACETABULAR AUGMENT, XX-YYY-ZZZZ
K001471 · LWJ
Implex Corp.
Orthopedic · 88d
Cleared Aug 07, 2000
LACTOSORB PANELS AND FASTENERS
K984390 · HRS
Biomet, Inc.
Orthopedic · 608d
Cleared Aug 04, 2000
APEX MODULAR HIP STEM
K000788 · LPH
Apex Surgical, LLC
Orthopedic · 147d
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