FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,766 results
7393–7416 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 16, 2012
SMITH & NEPHEW R3 CONSTRAINED LINERS
K122139 · KWZ
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Oct 16, 2012
TOWERLOX PEDICLE SCREW SYSTEM
K122332 · MNI
Captiva Spine
Orthopedic · 75d
Cleared Oct 15, 2012
SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM
K121627 · MEH
Smith & Nephew, Inc.
Orthopedic · 133d
Cleared Oct 15, 2012
ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR...
K122497 · KWQ
Medical Design, LLC
Orthopedic · 60d
Cleared Oct 12, 2012
TREGOR DUAL MOBILITY ACETABULAR SYSTEM
K111981 · LZO
Aston Medical
Orthopedic · 458d
Cleared Oct 12, 2012
UNISYN PLUS HIP STEM
K120595 · LWJ
Consensus Orthopedics, Inc.
Orthopedic · 227d
Cleared Oct 12, 2012
ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM
K121651 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 129d
Cleared Oct 12, 2012
IFUSE IMPLANT SYSTEM
K122074 · OUR
SI-BONE, Inc.
Orthopedic · 88d
Cleared Oct 12, 2012
PIONEER STERNAL CABLE PLATE SYSTEM
K122293 · HRS
Pioneer Surgical Technology, Inc.
Orthopedic · 73d
Cleared Oct 11, 2012
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, BASE PLATES & HUMERAL STEMS
K121543 · KWT
Zimmer, Inc.
Orthopedic · 139d
Cleared Oct 11, 2012
VISUALIF CHALLENGING ACCESS PLATE
K122168 · OVD
Spine Smith Partners L.P.
Orthopedic · 80d
Cleared Oct 11, 2012
CAPSURE(R) PS SYSTEM
K122233 · MNI
Spine Wave, Inc.
Orthopedic · 77d
Cleared Oct 11, 2012
APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT...
K122463 · MBI
Cayenne Medical, Inc.
Orthopedic · 59d
Cleared Oct 11, 2012
PROFEMUR Z REVISION HIP STEM
K122778 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 30d
Cleared Oct 11, 2012
INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL
K122798 · LPH
Exactech, Inc.
Orthopedic · 29d
Cleared Oct 11, 2012
ARCHON ANTERIOR CERVICAL PLATE SYSTE,
K122910 · KWQ
Nu Vasive, Incorporated
Orthopedic · 20d
Cleared Oct 10, 2012
FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTH
K122504 · LPH
United Orthopedic Corporation
Orthopedic · 55d
Cleared Oct 09, 2012
VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE)
K112837 · JDR
Vilex, Inc.
Orthopedic · 377d
Cleared Oct 09, 2012
NEXTRA TI HAMMERTOE CORRECTION SYSTEM
K122031 · HWC
Nextremity Solutions, LLC
Orthopedic · 90d
Cleared Oct 09, 2012
CROSS-OVER ACETABULAR SHELL & LINER
K122773 · OQG
Stelkast Company
Orthopedic · 29d
Cleared Oct 05, 2012
SMITH & NEPHEW RADIOPAQUE TRIAL NECKS
K113039 · MEH
Smith & Nephew, Inc.
Orthopedic · 359d
Cleared Oct 05, 2012
ALAMO T
K120401 · MAX
Alliance Partners, LLC
Orthopedic · 240d
Cleared Oct 05, 2012
CORIN TRIFIT TS HIP
K121563 · MEH
Corin USA
Orthopedic · 129d
Cleared Oct 05, 2012
TIGER SPINE SYSTEM
K121728 · NKB
Corelink, LLC
Orthopedic · 115d