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
13273–13296 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
Cleared May 10, 2000
KEYSTONE HIP
K000521 · LPH
Encore Orthopedics, Inc.
Orthopedic · 84d
Cleared May 10, 2000
COLORADO II SPINAL SYSTEM
K991031 · MNH
Sofamor Danek USA,Inc.
Orthopedic · 408d
Cleared May 05, 2000
PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601
K000734 · KTT
Pioneer Surgical Technology
Orthopedic · 59d
Cleared May 04, 2000
SHUTTLE STOP
K000587 · LZN
Isotis NV
Orthopedic · 72d
Cleared May 04, 2000
VULCAN ELECTROSURGICAL PROBES: VULCAN MICRO LIGAMENT CHISELS, VULCAN LIGAMENT...
K000691 · HRX
Oratec Interventions, Inc.
Orthopedic · 65d
Cleared May 04, 2000
CEMSTOP CEMENT RESTRICTOR
K993841 · LZN
Encore Orthopedics, Inc.
Orthopedic · 174d
Cleared May 04, 2000
MODULAR-PLUS REVISION STEM
K994126 · LWJ
Plus Orthopedics
Orthopedic · 149d
Cleared May 01, 2000
BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324B
K000506 · MAI
Arthrex, Inc.
Orthopedic · 76d
Cleared May 01, 2000
SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM
K000682 · KTT
Synthes (Usa)
Orthopedic · 62d