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
15145–15168 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 31, 1994
DEPUY POROUS COATED GLOBAL SHOULDER
K943300 · KWS
Depuy, Inc.
Orthopedic · 115d
Cleared Oct 26, 1994
HOWMEDICA PREMIUM FEMORAL COMPONENT
K936127 · JDI
Howmedica, Inc.
Orthopedic · 307d
Cleared Oct 20, 1994
CRUCIATE RETAINING CEMENTED TIBIAL COMPONENTS
K932776 · JWH
Exactech, Inc.
Orthopedic · 499d
Cleared Oct 20, 1994
ANTERIOR SPINE SYSTEM
K934429 · KWQ
Buckman Co., Inc.
Orthopedic · 402d
Cleared Oct 20, 1994
EXACTECH POROUS COATED CRUCIATE RETAINED FEMORAL COMPONENT
K935726 · JWH
Exactech, Inc.
Orthopedic · 323d
Cleared Oct 20, 1994
HOWMEDICS DRG FEMORAL COMPONENT
K936126 · JDI
Howmedica, Inc.
Orthopedic · 301d
Cleared Oct 20, 1994
COHORT AVB RETRACTOR SYSTEM
K943472 · HXB
Cohort Medical Products Group, Inc.
Orthopedic · 93d
Cleared Oct 19, 1994
J.B.S. IMPLANTABLE SPINAL FIXATION DEVICE
K935113 · KWP
J.B.S., S.A.
Orthopedic · 359d
Cleared Oct 19, 1994
INNOVASIVE SUTURE BONE FASTENER WITH SUTURE
K935321 · JDR
Innovasive Devices, Inc.
Orthopedic · 349d
Cleared Oct 19, 1994
AIMS CANNULATED ACL SCREW
K943539 · HWC
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Oct 18, 1994
AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER
K926334 · JWH
Orthomet, Inc.
Orthopedic · 671d
Cleared Oct 17, 1994
ZIRCONIA CERAMIC MODULAR HEADS (ASTRO MET)
K943586 · LZO
Biomet, Inc.
Orthopedic · 87d
Cleared Oct 14, 1994
PROXIMAL HUMERAL REPLACEMENT SYSTEM
K925613 · KWT
Biomet, Inc.
Orthopedic · 708d
Cleared Oct 14, 1994
ORTHOMET ACETABULAR CUP SYSTEM
K931333 · LPH
Orthomet, Inc.
Orthopedic · 577d
Cleared Oct 14, 1994
AXIOM TOTAL KNEE SYSTEM
K932677 · JWH
Orthomet, Inc.
Orthopedic · 499d
Cleared Oct 14, 1994
SOLUTION BOWED FEMORAL HIP PROTSTHESIS
K933942 · LZO
Depuy, Inc.
Orthopedic · 428d
Cleared Oct 14, 1994
ANATOMIC PROPORTIONAL SHOULDER APS (HEMI-SHOULDER) SYSTEM
K935593 · HSD
Biodynamic Technologies, Inc.
Orthopedic · 329d
Cleared Oct 14, 1994
PRESERVATION UNICOMPARTMENTAL KNEE
K941606 · HSX
Depuy, Inc.
Orthopedic · 196d
Cleared Oct 14, 1994
AML TRILOCK REPLACEMENT LINER SYSTEM
K942966 · JDI
Depuy, Inc.
Orthopedic · 116d
Cleared Oct 14, 1994
AML TRI-LOCK REPLACEMENT LINER SYSTEM
K943302 · JDI
Depuy, Inc.
Orthopedic · 98d
Cleared Oct 14, 1994
CANNULATED BONE SCREW
K943474 · HWC
Cohort Medical Products Group, Inc.
Orthopedic · 87d
Cleared Oct 13, 1994
PARADIGM FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM
K931423 · LWJ
Orthomed
Orthopedic · 570d
Cleared Oct 11, 1994
CKS POROUS COATED FEMORAL COMPONENT
K933935 · HRY
Techmedica, Inc.
Orthopedic · 426d
Cleared Oct 11, 1994
ALTA FEMORAL INTRAMEDULLARY RODS/CFX RODS MODIFICATION
K935295 · HSB
Howmedica Corp.
Orthopedic · 343d