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
14137–14160 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 02, 1997
PROFORM GENERAL APPLICATION CEMENTED FEMORAL COMPONENT
K970490 · LZO
Stelkast Company
Orthopedic · 81d
Cleared May 02, 1997
ACPII ANTERIOR CERVICAL PLATE SYSTEM
K970806 · KWQ
Sofamor Danek USA,Inc.
Orthopedic · 58d
Cleared Apr 30, 1997
STRYKER 2115 REPLACEMENT BATTERY (2115)
K970378 · KIJ
Implant Resource, Inc.
Orthopedic · 89d
Cleared Apr 30, 1997
INNOVASIVE ROCLET BONE TUNNEL AUGMENTATION DEVICE
K970423 · MBI
Innovasive Devices, Inc.
Orthopedic · 85d
Cleared Apr 30, 1997
IMPLEX BIPOLAR HIP SYSTEM
K970447 · KWY
Implex Corp.
Orthopedic · 83d
Cleared Apr 30, 1997
NATURAL-KNEE II REVISION FEMORAL SPACER LUGS
K970498 · JWH
Intermedics Orthopedics
Orthopedic · 79d
Cleared Apr 30, 1997
PEGGED ACETABULAR COMPONENT
K970501 · LPH
Biomet, Inc.
Orthopedic · 79d
Cleared Apr 30, 1997
DEPUY ACE TROCHANTERIC SIDE PLATE
K970503 · HRS
Depuy Ace Medical Co.
Orthopedic · 79d
Cleared Apr 30, 1997
TITANIUM ALLOY BONE SCREWS
K970549 · HWC
Aesculap, Inc.
Orthopedic · 77d
Cleared Apr 29, 1997
ALIGNMENT INSTRUMENT
K970345 · HSZ
Richard Wolf Medical Instruments Corp.
Orthopedic · 90d
Cleared Apr 28, 1997
ALPHATEC EXTERNAL FIXATION SYSTEM
K964400 · KTT
Alphatec Mfg., Inc.
Orthopedic · 175d
Cleared Apr 24, 1997
OSTEONICS NORMALIZED AD ACETABULAR COMPONENT SYSTEM
K970697 · JDI
Osteonics Corp.
Orthopedic · 58d
Cleared Apr 23, 1997
SERVOTRONIC EC100 SYSTEM
K962087 · HWE
Medicon, Inc.
Orthopedic · 330d
Cleared Apr 23, 1997
IN-FAST BONE SCREW SYSTEM/IN-FAST BONE SCREW INSERTER/IN-FAST BONE SCREW
K970292 · MBI
Influence, Inc.
Orthopedic · 89d
Cleared Apr 22, 1997
OSTEONICS NORMALIZED AD-HA ACETABULAR COMPONENT SYSTEM
K970394 · MEH
Osteonics Corp.
Orthopedic · 78d
Cleared Apr 21, 1997
TITANIUM LIBERTY POSTERIOR SPINAL SYSTEM
K964254 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 179d
Cleared Apr 21, 1997
ARTOS, DIPLOS SYSTEM
K970284 · KWY
Turnkey Intergration USA, Inc.
Orthopedic · 87d
Cleared Apr 21, 1997
BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM
K970897 · HSB
Biodynamic Technologies, Inc.
Orthopedic · 41d
Cleared Apr 16, 1997
INNOVASIVE 8MM LIGAMENT FASTENER
K970316 · MBI
Innovasive Devices, Inc.
Orthopedic · 82d
Cleared Apr 16, 1997
HEIDELBERG EXTERNAL FIXATOR
K970751 · JDW
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 44d
Cleared Apr 14, 1997
PROFORM CEMENTED TITANIUM REVISION FEMORAL COMPONENT
K970194 · JDI
Stelkast Company
Orthopedic · 83d
Cleared Apr 09, 1997
EBI SPINELINK SYSTEM
K964533 · MNH
Electro-Biology, Inc.
Orthopedic · 148d
Cleared Apr 09, 1997
RELIANCE PF FEMORAL STEMS
K970200 · LZO
Howmedica Corp.
Orthopedic · 78d
Cleared Apr 08, 1997
NATURAL-HIP SYSTEM COCR REVISION STEM
K970166 · LZO
Intermedics Orthopedics
Orthopedic · 82d