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
11761–11784 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 23, 2004
SUSTAIN RADIOLUCENT SPACER
K040284 · MQP
Globus Medical, Inc.
Orthopedic · 46d
Cleared Mar 23, 2004
TRIGEN TROCHANTERIC ANTEGRADE NAIL
K040462 · HSB
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Mar 19, 2004
MODIFICATION TO VERTE-STACK
K040422 · MQP
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Mar 12, 2004
SPECTRUM MODULAR SYSTEM
K033893 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 87d
Cleared Mar 12, 2004
STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD
K033944 · LZO
Stelkast Company
Orthopedic · 84d
Cleared Mar 12, 2004
STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM
K040022 · HRS
Stryker Leibinger
Orthopedic · 65d
Cleared Mar 12, 2004
TRIMED BEARING PLATE
K040112 · HRS
Tri-Med, Inc.
Orthopedic · 52d
Cleared Mar 12, 2004
MODIFICATION TO ORIA TOP CLIP SYSTEM
K040346 · MNI
Ortho Tec, LLC
Orthopedic · 29d
Cleared Mar 11, 2004
GLOBAL RESURFACING UNICOMPARTMENTAL (GRU) KNEE
K033351 · HRY
Global Orthopaedic Technology, USA, Inc.
Orthopedic · 143d
Cleared Mar 11, 2004
ATH FEMORAL STEM
K034028 · JDI
Wrightmedicaltechnologyinc
Orthopedic · 73d
Cleared Mar 09, 2004
ARROWHEAD SPINAL SYSTEM
K032560 · NKB
Medtronic Sofamor Danek
Orthopedic · 202d
Cleared Mar 09, 2004
BONESAVE BONE VOID FILLER
K033258 · MQV
Howmedica Osteonics
Orthopedic · 152d
Cleared Mar 09, 2004
THERILINK BONE VOID FILLER
K040134 · MQV
Therics, Inc.
Orthopedic · 48d
Cleared Mar 05, 2004
ALLOMATRIX MODEL# 86
K020895 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 717d
Cleared Mar 05, 2004
DYNESYS SPINAL SYSTEM
K031511 · NQP
Centerpulse Spine-Tech, Inc.
Orthopedic · 296d
Cleared Mar 05, 2004
NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM
K033810 · HRY
Centerpulse Orthopedics, Inc.
Orthopedic · 88d
Cleared Mar 05, 2004
CEM-OSTETIC PUTTY INJECTION KIT, MODEL PIK-XX, PIK-XX-YY
K040405 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 17d
Cleared Mar 04, 2004
SYNTHES VENTROFIX MIS SYSTEM
K031100 · KWQ
Synthes (Usa)
Orthopedic · 332d
Cleared Mar 04, 2004
SHIRAZ POSTERIOR SYSTEM
K033947 · MNI
Spine Next America
Orthopedic · 76d
Cleared Mar 04, 2004
SHIRAZ-ANTERIOR SYSTEM
K033965 · KWQ
Spine Next America
Orthopedic · 73d
Cleared Mar 03, 2004
BLACKSTONE ASCENT POCT SYSTEM HOOKS (SYSTEM MODIFICATION)
K033980 · KWP
Blackstone Medical, Inc.
Orthopedic · 71d
Cleared Mar 02, 2004
SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM
K033816 · JDQ
Synthes (Usa)
Orthopedic · 84d
Cleared Mar 01, 2004
CANNULATED METALLIC HEMI TOE IMPLANT, MODELS MPJ241975, MPJ221775, MPJ211675,...
K023684 · KWD
Vilex, Inc.
Orthopedic · 486d
Cleared Mar 01, 2004
INION OTPS BIODEGRADABLE MESH PLATING SYSTEM
K031961 · HRS
Inion , Ltd.
Orthopedic · 250d