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
11617–11640 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 26, 2004
ICON POLYAXIAL PEDICLE SCREW SYSTEM
K033090 · KWP
Alphatec Mfg., Inc.
Orthopedic · 179d
Cleared Mar 26, 2004
VERTEBRON SCP CERVICAL PLATE SYSTEM
K040003 · KWQ
Vertebron, Inc.
Orthopedic · 84d
Cleared Mar 26, 2004
MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS
K040128 · HSD
Howmedica Osteonics Corp.
Orthopedic · 65d
Cleared Mar 26, 2004
ANTERIOR LUMBAR BUTTRESS SYSTEM
K040130 · KWQ
Seaspine
Orthopedic · 65d
Cleared Mar 26, 2004
CERASORB M ORTHO
K040216 · MQV
Curasan AG
Orthopedic · 56d
Cleared Mar 23, 2004
ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTS
K033109 · MQP
Scient'X
Orthopedic · 175d
Cleared Mar 23, 2004
NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR
K040064 · KTT
Newmedical Technology, Inc.
Orthopedic · 70d
Cleared Mar 23, 2004
BONE-LOK HP WASHER
K040250 · HTN
Triage Medical, Inc.
Orthopedic · 50d
Cleared Mar 23, 2004
SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE
K040258 · KTT
Synthes (Usa)
Orthopedic · 48d
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