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
12193–12216 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 25, 2002
LEFORTE SYSTEM BONE PLATE
K023360 · KTW
Jeil Medical Corporation
Orthopedic · 18d
Cleared Oct 25, 2002
MODIFICATION TO ESOP CO-CR FEMORAL HEADS
K023375 · LPH
Pro-Active Healthcare
Orthopedic · 17d
Cleared Oct 25, 2002
EBI XFIX DFS SYSTEM
K023399 · KTT
Ebi, L.P.
Orthopedic · 16d
Cleared Oct 18, 2002
DURACON CS TIBIAL INSERT
K021451 · JWH
Howmedica Osteonics Corp.
Orthopedic · 165d
Cleared Oct 18, 2002
VKS KNEE SYSTEM
K022204 · JWH
Plus Orthopedics
Orthopedic · 105d
Cleared Oct 18, 2002
MODIFICATION TO EBI VUELOCK ANTERIOR CERVICAL PLATE SYSTEM
K023133 · KWQ
Ebi, L.P.
Orthopedic · 28d
Cleared Oct 18, 2002
MODIFICATION TO EBI OMEGA21 SPINAL FIXATION SYSTEM
K023204 · MNH
Ebi, L.P.
Orthopedic · 23d
Cleared Oct 18, 2002
1.2MM OSTEOMED AUTO-DRIVE SCREW SYSTEM
K023260 · HWC
Osteomed Corp.
Orthopedic · 18d
Cleared Oct 18, 2002
MICROFIX
K023314 · KTT
Fixano SA
Orthopedic · 45d
Cleared Oct 18, 2002
MODIFICATION TO EBI XFIX DFS SYSTEM
K023324 · KTT
Ebi, L.P.
Orthopedic · 14d
Cleared Oct 17, 2002
BIOSTEON CROSS PIN
K021351 · HWC
Biocomposites, Ltd.
Orthopedic · 171d
Cleared Oct 17, 2002
GMRS PRESS FIT STEMS WITH PUREFIX HA
K022403 · LZO
Howmedica Osteonics Corp.
Orthopedic · 86d
Cleared Oct 17, 2002
HOFFMANN 30 DEGREE PELVIC DOUBLE BALL JOINT
K022651 · LXT
Howmedica Osteonics Corp.
Orthopedic · 69d
Cleared Oct 17, 2002
RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM
K023085 · JDI
Biomet Orthopedics, Inc.
Orthopedic · 30d
Cleared Oct 17, 2002
OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY
K023186 · JWH
Exactech, Inc.
Orthopedic · 23d
Cleared Oct 17, 2002
OSSTAPLE
K023203 · JDR
Biomedical Ent., Inc.
Orthopedic · 22d
Cleared Oct 17, 2002
NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR)-FLEX FEMORAL COMPONENTS
K023211 · JWH
Zimmer, Inc.
Orthopedic · 21d
Cleared Oct 09, 2002
SMITH & NEPHEW SURETAC - EXPANDED INDICATIONS II
K020948 · JDR
Smith & Nephew, Inc.
Orthopedic · 198d
Cleared Oct 09, 2002
ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM
K023102 · MEH
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Oct 09, 2002
JET-X TIN COATED HALF PINS
K023134 · JDW
Smith & Nephew, Inc.
Orthopedic · 19d
Cleared Oct 09, 2002
BOSWORTH CORACO-CLAVICULAR SCREW
K023294 · HWC
Howmedica Osteonics Corp.
Orthopedic · 7d
Cleared Oct 04, 2002
NBD CEMENT RESTRICTOR DEVICE
K021788 · JDK
New Business Development, LLC
Orthopedic · 126d
Cleared Oct 04, 2002
AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM
K022207 · MBI
Axya Medical, Inc.
Orthopedic · 88d
Cleared Oct 04, 2002
RHS ACETABULAR COMPONENT
K022382 · LPH
Signal Medical Corp.
Orthopedic · 74d