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
12193–12216 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 26, 2003
STRYKER XCEL ANCHOR SYSTEM
K023013 · HWC
Stryker Endoscopy
Orthopedic · 169d
Cleared Feb 26, 2003
VERTE-SPAN SPINAL SYSTEM
K024049 · MQP
Medtronic Sofamor Danek, Inc.
Orthopedic · 79d
Cleared Feb 26, 2003
SMITH & NEPHEW FEMORAL HEADS
K024340 · JDI
Smith & Nephew, Inc.
Orthopedic · 61d
Cleared Feb 26, 2003
CALCIGEN PSI BONE GRAFT SUBSTITUTE
K030178 · MQV
Biomet, Inc.
Orthopedic · 40d
Cleared Feb 26, 2003
ZEPHIR ANTERIOR CERVICAL SYSTEM
K030327 · KWQ
Medtronic Sofamor Danek
Orthopedic · 26d
Cleared Feb 26, 2003
MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS
K030383 · MNH
Depuyacromed
Orthopedic · 21d
Cleared Feb 25, 2003
JAX
K010555 · MQV
Smith & Nephew, Inc.
Orthopedic · 729d
Cleared Feb 25, 2003
U2 ACETABULAR CUP
K022520 · LPH
United Orthopedic Corp.
Orthopedic · 210d
Cleared Feb 25, 2003
MODIFICATION TO TSRH SPINAL SYSTEM
K030285 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Feb 25, 2003
UNICONDYLAR FEMORAL COMPONENT
K030301 · JWH
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Feb 21, 2003
MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM
K030241 · KWP
Blackstone Medical, Inc.
Orthopedic · 29d
Cleared Feb 21, 2003
ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07)
K030252 · KWP
Ortho Tec, LLC
Orthopedic · 28d
Cleared Feb 21, 2003
ORIA SPINAL CLIP SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06
K030253 · KWP
Ortho Tec, LLC
Orthopedic · 28d
Cleared Feb 20, 2003
ADVANCE LESS CONFORMING TIBIAL COMPONENT
K030193 · HRY
Wrightmedicaltechnologyinc
Orthopedic · 30d
Cleared Feb 20, 2003
DYONICS POWER CONTROL UNIT
K030196 · HRX
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Feb 20, 2003
ACUMATCH P-SERIES POROUS PRESS-FIT FEMORAL COMPONENT
K030236 · LPH
Exactech, Inc.
Orthopedic · 28d
Cleared Feb 20, 2003
CEM-OSTETIC BONE
K030266 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 24d
Cleared Feb 14, 2003
SURGICAL TITANIUM MESH SYSTEM
K030249 · MQP
Depuyacromed
Orthopedic · 21d
Cleared Feb 13, 2003
SMARTSET HV BONE CEMENT
K023012 · LOD
DePuy Orthopaedics, Inc.
Orthopedic · 156d
Cleared Feb 13, 2003
DAVOL ARTHROVENT OUTFLOW TUBING
K030307 · HRX
Davol, Inc.
Orthopedic · 15d
Cleared Feb 07, 2003
SOHNIKS
K023783 · HRX
Sohniks Endoscopy, Inc.
Orthopedic · 87d
Cleared Feb 06, 2003
FASSIRE-DUVAL TELESCOPIC IM SYSTEM
K020885 · HSB
Pega Medical, Inc.
Orthopedic · 325d
Cleared Feb 06, 2003
KOMPRESSOR SCREW SYSTEM
K024233 · HWC
Kinetikos Medical, Inc.
Orthopedic · 45d
Cleared Feb 05, 2003
SMALL TITANIUM WRIST FUSION PLATE
K023879 · HRS
Synthes (Usa)
Orthopedic · 76d