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
12049–12072 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 06, 2003
MODIFICATION TO SYNTHES CERVIFIX SYSTEM
K030377 · MNI
Synthes (Usa)
Orthopedic · 29d
Cleared Mar 06, 2003
REPICCI LOCKED KEEL TIBIAL BEARING
K030446 · HRY
Biomet, Inc.
Orthopedic · 23d
Cleared Mar 04, 2003
ESKA MODULAR HIP SYSTEM ACETABULAR COMPONENTS
K021878 · LPH
Eska America Corp.
Orthopedic · 270d
Cleared Mar 04, 2003
NUVASIVE MASH
K023319 · MQP
Nuvasive, Inc.
Orthopedic · 151d
Cleared Mar 04, 2003
ORIA CERVICAL PLATES
K023377 · KWQ
Ortho Tec, LLC
Orthopedic · 147d
Cleared Mar 04, 2003
MIIG II BONE GRAFT SUBSTITUTE
K024336 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 67d
Cleared Mar 04, 2003
CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00
K030265 · JDI
Zimmer, Inc.
Orthopedic · 36d
Cleared Mar 04, 2003
MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS
K030344 · KWS
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Feb 26, 2003
PALABOND
K022251 · LOD
Heraeus Kulzer GmbH & Co. KG
Orthopedic · 229d
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