FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Orthopedic ×
17,985 results
11401–11424 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 21, 2004
APEX K2 HIP SYSTEM
K041950 · LPH
Apex Surgical, LLC
Orthopedic · 154d
Cleared Dec 21, 2004
VERTEX RECONSTRUCTION SYSTEM
K042789 · KWP
Medtronic Sofamor Danek
Orthopedic · 76d
Cleared Dec 21, 2004
M2A/C2A ACETABULAR SYSTEM
K042841 · JDL
Biomet, Inc.
Orthopedic · 68d
Cleared Dec 21, 2004
TRABECULAR METAL ACETABULAR AUGMENTS, MODELS 4894-XXX-YY, 02-212-105XX3,...
K042871 · LPH
Zimmer Trabecular
Orthopedic · 64d
Cleared Dec 21, 2004
MODIFICATION TO ALTIUS OCT SYSTEM
K043229 · KWP
Interpore Cross Intl.
Orthopedic · 29d
Cleared Dec 21, 2004
UCR SPINAL SYSTEM
K043232 · NKB
Seaspine
Orthopedic · 29d
Cleared Dec 20, 2004
OSS/(SCARF)- AND OSW-SCREW
K042079 · HWC
O.M.T. Oberflachen-Und...
Orthopedic · 140d
Cleared Dec 17, 2004
POLYGRAFT BGS
K040047 · MQV
Osteobiologics, Inc.
Orthopedic · 340d
Cleared Dec 17, 2004
TRANS1 AXIAL FIXATION SYSTEM
K040426 · KWQ
Trans1, Inc.
Orthopedic · 302d
Cleared Dec 17, 2004
CONSERVE PLUS HA ACETABULAR SHELLS
K042530 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 91d
Cleared Dec 17, 2004
MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM
K043077 · KWS
Tornier
Orthopedic · 39d
Cleared Dec 17, 2004
MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM
K043181 · KWQ
Vertebron, Inc.
Orthopedic · 30d
Cleared Dec 17, 2004
SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS,...
K043355 · KWP
Sintea Biotech, Inc.
Orthopedic · 11d
Cleared Dec 14, 2004
PLLA CANNULATED INTERFERENCE SCREW
K032830 · HWC
Advanced Biomaterials
Orthopedic · 460d
Cleared Dec 14, 2004
BIO-CORE INTERFERENCE SCREW
K042552 · HWC
Biomet, Inc.
Orthopedic · 85d
Cleared Dec 14, 2004
OPUS MINIMAGNUM ANCHOR WITH INSERTER
K042584 · HWC
Opus Medical, Inc.
Orthopedic · 83d
Cleared Dec 14, 2004
BIOPLUS
K042636 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 78d
Cleared Dec 14, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K042962 · NKB
Medtronic Sofamor Danek
Orthopedic · 48d
Cleared Dec 14, 2004
ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR
K043337 · HWC
Arthrex, Inc.
Orthopedic · 11d
Cleared Dec 13, 2004
EBI ARRAY SPINAL FIXATION SYSTEM AND SPINELINK II SPINAL FIXATION DEVICE
K042772 · NKB
Ebi, L.P.
Orthopedic · 69d
Cleared Dec 10, 2004
PERIARTICULAR LOCKING PLATES, 2358 SERIES
K043227 · HRS
Zimmer, Inc.
Orthopedic · 18d
Cleared Dec 08, 2004
LPS UPPER EXTREMITY
K042664 · JDC
Depuy, Inc.
Orthopedic · 71d
Cleared Dec 08, 2004
BICONTACT HIP SYSTEM WITH U-CAP
K043079 · MEH
Aesculap
Orthopedic · 30d
Cleared Dec 07, 2004
AEQUOS
K033260 · JWH
Aap Implantate AG
Orthopedic · 425d