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
12793–12816 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Sep 24, 2001
AOS MODULAR FEMORAL NAIL
K012190 · HSB
Advanced Orthopaedic Solutions, Inc.
Orthopedic · 73d
Cleared Sep 24, 2001
XIA STAINLESS STEEL SYSTEM
K012870 · KWP
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Sep 20, 2001
COLLAGRAFT STRIP BONE GRAFT MATRIX (FOR USE AS A BONE FILLER), MODEL 1X,3X,6X...
K000122 · MQV
Neucoll, Inc.
Orthopedic · 611d
Cleared Sep 19, 2001
IMPRO VISE ABSORBABLE CEMENT FLOW RESTRICTOR
K011943 · LZN
Kensey Nash Corp.
Orthopedic · 90d
Cleared Sep 19, 2001
SULZER ORTHOPEDICS ALLEGRETTO UNICOMPARTMENTAL KNEE
K011954 · HSX
Sulzer Orthopedics, Inc.
Orthopedic · 89d
Cleared Sep 19, 2001
CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116
K012334 · MAI
Bionx Implants, Inc.
Orthopedic · 57d
Cleared Sep 17, 2001
OPUS MAGNUM ANCHOR & INSERTER
K012125 · HTY
Opus Medical, Inc.
Orthopedic · 73d
Cleared Sep 14, 2001
COPELAND MB RESURFACING HUMERAL HEADS
K010657 · HSD
Biomet Manufacturing, Inc.
Orthopedic · 192d
Cleared Sep 14, 2001
COPELAND MB/HA RESURFACING HUMERAL HEADS
K010827 · HSD
Biomet Orthopedics, Inc.
Orthopedic · 178d
Cleared Sep 13, 2001
SYNERGY TI INTEGRAL OPEN SCREWS MODELS # 6193, 6194, 6195,6196, 6173, 6174,...
K012871 · KWP
Interpore Cross Intl.
Orthopedic · 17d
Cleared Sep 12, 2001
SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM
K011857 · HSB
Synthes (Usa)
Orthopedic · 90d
Cleared Sep 11, 2001
ARTSCAN CARTILAGE STIFFNESS TESTING DEVICE
K010303 · NGR
Artscan Medical Innovations
Orthopedic · 280d
Cleared Sep 07, 2001
ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING
K011810 · KRO
Depuy, Inc.
Orthopedic · 88d
Cleared Sep 07, 2001
MPF ACETABULAR CUP
K011836 · LZO
Plus Orthopedics
Orthopedic · 87d
Cleared Sep 06, 2001
SYNTHES LCP PROXIMAL HUMERUS PLATES
K011815 · KTW
Synthes (Usa)
Orthopedic · 87d
Cleared Sep 06, 2001
MODIFICATION TO THE I.C.O.S SCREW
K011821 · HWC
New Deal, S.A.
Orthopedic · 87d
Cleared Sep 06, 2001
MODIFICATION TO THE TAC' PIN
K011875 · JDW
New Deal, S.A.
Orthopedic · 83d
Cleared Sep 05, 2001
R120 MODULAR TOTAL HIP SYSTEM
K011774 · JDI
Osteoimplant Technology, Inc.
Orthopedic · 90d
Cleared Aug 31, 2001
MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000
K011912 · MBI
Axya Medical, Inc.
Orthopedic · 73d
Cleared Aug 31, 2001
STRYKER PLATING SYSTEM BASIC FRAGMENT SET
K012162 · HRS
Howmedica Osteonics Corp.
Orthopedic · 51d
Cleared Aug 30, 2001
THE UNI-CLIP STAPLE
K011716 · JDR
New Deal, S.A.
Orthopedic · 87d
Cleared Aug 30, 2001
THE TRABECULAR METAL TECHNOLOGY ACETABULAR AUGMENT SYSTEM, MODELS 4893-XX-YY...
K012507 · LPH
Implex Corp.
Orthopedic · 24d
Cleared Aug 29, 2001
VULCAN TAC PROBES, MODEL 911XXX
K003198 · HRX
Oratec Interventions, Inc.
Orthopedic · 321d
Cleared Aug 29, 2001
ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0
K012493 · JDI
Exactech, Inc.
Orthopedic · 26d