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
15001–15024 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 05, 1995
PROVIDENT HP SYSTEM
K946371 · JDI
Stelkast Company
Orthopedic · 120d
Cleared Apr 04, 1995
ADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEM
K944092 · JEC
Orthofix Srl
Orthopedic · 225d
Cleared Mar 30, 1995
FOUNDATION NON-POROUS STEM
K935449 · JDI
Encore Orthopedics, Inc.
Orthopedic · 503d
Cleared Mar 24, 1995
MITEK G III ANCHOR, MITEK LS ANCHOR
K944936 · JDR
Mitek Surgical Products, Inc.
Orthopedic · 169d
Cleared Mar 22, 1995
DURACON STABILIZER FEMORAL COMPONENT AND INSERT
K932070 · JWH
Howmedica Corp.
Orthopedic · 693d
Cleared Mar 22, 1995
FMS ARTHROSCOPY CANNULA
K945973 · HRX
Future Medical Systems, Inc.
Orthopedic · 104d
Cleared Mar 21, 1995
FEMROD AND FEMROD RECON INSERT
K935383 · HSB
Applied Osteo Systems, Inc.
Orthopedic · 498d
Cleared Mar 21, 1995
HOWMEDICA V40 22MM FEMORAL HEAD
K950541 · LWJ
Howmedica Corp.
Orthopedic · 42d
Cleared Mar 20, 1995
BIOABSORBABLE INTERFERENCE SCREW
K943548 · JDR
Acufex Microsurgical, Inc.
Orthopedic · 242d
Cleared Mar 20, 1995
HOWMEDICA(R) 28MM ZIRCONIA FEMORAL HEADS
K946026 · LZO
Howmedica, Inc.
Orthopedic · 98d
Cleared Mar 17, 1995
ORTHOLOC ADVANTIM POROUS COATED TIBIAL BASE
K945087 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 151d
Cleared Mar 17, 1995
OSTEONICS(R) THREADED HA ACETABULAR SHELLS
K945691 · MEH
Osteonics Corp.
Orthopedic · 116d
Cleared Mar 17, 1995
TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER
K946313 · HRX
Smith and Nephew Donjoy, Inc.
Orthopedic · 79d
Cleared Mar 15, 1995
OSTEONICS SECURE-FIT AD-HA ACETABULAR COMPONENT SYSTEM
K942900 · MEH
Osteonics Corp.
Orthopedic · 268d
Cleared Mar 13, 1995
ARTHROCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM MODEL 970
K943450 · HRX
Arthrocare Corp.
Orthopedic · 238d
Cleared Mar 10, 1995
EXACTECH POSTERIOR STABILIZED CEMENTED TOTAL KNEE SYSTEM
K933494 · JWH
Exactech, Inc.
Orthopedic · 599d
Cleared Mar 10, 1995
SPINALPLANE
K934336 · HSZ
Synvasive Technology, Inc.
Orthopedic · 549d
Cleared Mar 07, 1995
BIAS(TM) FIBER METAL TOTAL HIP STEM (TFB)
K934515 · LPH
Zimmer, Inc.
Orthopedic · 538d
Cleared Mar 07, 1995
DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE
K945294 · JDQ
Howmedica Corp.
Orthopedic · 127d
Cleared Mar 07, 1995
KIRSCHNER (K-WIRE), STEINMAN PINS
K945670 · JDW
Brasseler USA I, L.P.
Orthopedic · 109d
Cleared Mar 06, 1995
MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM
K941534 · KWY
3M Health Care, Ltd.
Orthopedic · 341d
Cleared Mar 06, 1995
OSTEONICS RESTORATION MONOLITHIC HIP STEM
K943774 · LZO
Osteonics Corp.
Orthopedic · 216d
Cleared Mar 06, 1995
MANUAL INSTRUMENTS
K943937 · HRX
Pantheon Surgical Products
Orthopedic · 206d
Cleared Mar 06, 1995
RESTORATION HA ACETABULAR CUP SERIES
K943957 · MEH
Osteonics Corp.
Orthopedic · 203d