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
11833–11856 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Sep 22, 2003
ESKA MODULAR HIP SYSTEM CEMENTED
K030867 · JDI
Eska Implants GmbH
Orthopedic · 187d
Cleared Sep 22, 2003
ARTHREX TRIMIT SCREW, MODEL AR-4161B
K031945 · HWC
Arthrex, Inc.
Orthopedic · 90d
Cleared Sep 22, 2003
PROCLASS PRESS FIT HIP STEM
K032110 · LWJ
Stelkast Company
Orthopedic · 75d
Cleared Sep 22, 2003
CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING)
K032169 · LXT
Cyberorthology, Inc.
Orthopedic · 68d
Cleared Sep 22, 2003
ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM
K032187 · HRS
Arthrex, Inc.
Orthopedic · 67d
Cleared Sep 22, 2003
WAGNER CONE PROSTHESIS
K032380 · LZO
Centerpulse Orthopedics, Inc.
Orthopedic · 52d
Cleared Sep 17, 2003
SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM
K031855 · KWQ
Spinal Concepts, Inc.
Orthopedic · 93d
Cleared Sep 17, 2003
TSRH SPINAL SYSTEM
K031967 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 83d
Cleared Sep 17, 2003
SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES
K032269 · HRS
Synthes (Usa)
Orthopedic · 56d
Cleared Sep 17, 2003
TSRH SPINAL SYSTEM
K032578 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Sep 16, 2003
HYDROCISION ARTHROJET SYSTEM WITH CAUTERY, TURBOBURR AND CURETTE, MODELS...
K032529 · HRX
Hydrocision, Inc.
Orthopedic · 32d
Cleared Sep 15, 2003
ASAP ARTHROSCOPE MODELS
K031972 · HRX
Asap Endoscopic Products GmbH
Orthopedic · 81d
Cleared Sep 15, 2003
KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A
K032212 · HRX
Kyphon, Inc.
Orthopedic · 56d
Cleared Sep 12, 2003
CD HORIZON SPINAL SYSTEM
K032033 · NKB
Medtronic Sofamor Danek
Orthopedic · 73d
Cleared Sep 12, 2003
DURACON TOTAL KNEE SYSTEM
K032163 · MBH
Howmedica Osteonics Corp.
Orthopedic · 59d
Cleared Sep 12, 2003
MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM)
K032588 · HSB
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 21d
Cleared Sep 11, 2003
SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM
K031985 · MNI
Spinal Concepts, Inc.
Orthopedic · 76d
Cleared Sep 11, 2003
DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING
K032418 · MBH
Howmedica Osteonics Corp.
Orthopedic · 37d
Cleared Sep 10, 2003
IP-XS COMPRESSION NAIL SYSTEM
K032548 · HSB
Plus Orthopedics
Orthopedic · 23d
Cleared Sep 05, 2003
TI FENESTRATED PLATE
K031772 · KWP
Interpore Cross Intl.
Orthopedic · 88d
Cleared Sep 05, 2003
SYNTHES 4.0 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAFE
K031973 · LXT
Synthes (Usa)
Orthopedic · 71d
Cleared Sep 05, 2003
INTERLOK BIO-MODULAR HUMERAL STEMS
K032507 · KWT
Biomet, Inc.
Orthopedic · 22d
Cleared Sep 04, 2003
EBI XFIX DFS SYSTEM
K031919 · KTT
Ebi, L.P.
Orthopedic · 73d
Cleared Sep 04, 2003
ALANTECH GRAFT FIXATION SCREW
K031937 · HWC
Arthrocare Corp.
Orthopedic · 73d