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
13129–13152 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 12, 2000
SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM
K993335 · HTO
Synthes (Usa)
Orthopedic · 252d
Cleared Jun 08, 2000
OMEGA II MODULAR TOTAL HIP SYSTEM
K000817 · JDI
Osteoimplant Technology, Inc.
Orthopedic · 87d
Cleared Jun 08, 2000
BIOPRO GLENOID COMPONENT W/ KEEL & W/ POSTS
K001046 · KWS
Biopro, Inc.
Orthopedic · 69d
Cleared Jun 07, 2000
MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS
K001548 · KRO
Howmedica Osteonics Corp.
Orthopedic · 20d
Cleared Jun 07, 2000
WINDOW CERVICAL DYNAMIC PLATE SYSTEM
K993066 · KWQ
Advanced Spine Technology, Inc.
Orthopedic · 349d
Cleared Jun 05, 2000
BOFOR REVISION COUP
K993874 · LZO
Plus Orthopedics
Orthopedic · 203d
Cleared Jun 03, 2000
TRIFIX SPINAL FIXATION SYSTEM
K001627 · MNH
Endius, Inc.
Orthopedic · 8d
Cleared Jun 01, 2000
TRI-FIX SPINAL FIXATION SYSTEM
K000766 · MNI
Endius, Inc.
Orthopedic · 84d
Cleared May 23, 2000
REACH FEMORAL COMPONENT
K000760 · LPH
Biomet, Inc.
Orthopedic · 76d
Cleared May 23, 2000
HOFFMANN II EXTERNAL FIXATION SYSTEM
K000957 · LXT
Howmedica Osteonics Corp.
Orthopedic · 60d
Cleared May 23, 2000
PASS SPINAL SYSTEM
K001024 · MNH
Encore Orthopedics, Inc.
Orthopedic · 54d
Cleared May 23, 2000
CONTINUUM KNEE SYSTEM-PS FEMORAL COMPONENTS- POROUS, MODEL XX-YYY-ZZZZZ
K001307 · JWH
Implex Corp.
Orthopedic · 29d
Cleared May 23, 2000
XIA SPINE SYSTEM HOOKS
K001319 · MNH
Howmedica Osteonics Corp.
Orthopedic · 27d
Cleared May 23, 2000
EBI XFIX DFS METAPHYSEAL CORRECTION SYSTEM
K001358 · KTT
Ebi, L.P.
Orthopedic · 25d
Cleared May 23, 2000
NEER III TOTAL SHOULDER SYSTEM
K994350 · KWS
Smith & Nephew, Inc.
Orthopedic · 152d
Cleared May 18, 2000
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL L-SERIES CEMENTED
K001335 · JDI
Exactech, Inc.
Orthopedic · 21d
Cleared May 18, 2000
MODIFICATION TO DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS
K001451 · HRY
DePuy Orthopaedics, Inc.
Orthopedic · 9d
Cleared May 18, 2000
METAL ON METAL ACETABULAR SYSTEM
K993438 · KWA
Biomet, Inc.
Orthopedic · 219d
Cleared May 11, 2000
LATERAL PIVOT INSERT
K000590 · JWH
Encore Orthopedics, Inc.
Orthopedic · 80d
Cleared May 11, 2000
STRYKER TRAUMA PLATING SYSTEM
K000636 · HRS
Howmedica Osteonics Corp.
Orthopedic · 76d
Cleared May 11, 2000
ERS RADIAL HEAD REPLACEMENT
K000658 · KWI
DePuy Orthopaedics, Inc.
Orthopedic · 73d
Cleared May 11, 2000
PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF)
K000694 · JDQ
Pectofix, Inc.
Orthopedic · 71d
Cleared May 11, 2000
MULTI-AXIAL CROSS (MAC) CONNECTOR
K000965 · MNI
Howmedica Osteonics Corp.
Orthopedic · 45d
Cleared May 11, 2000
XIA SPINE SYSTEM
K001272 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 21d