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
12817–12840 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 27, 2001
MACROPORE IB RESORBABLE PLUG
K011715 · JDI
Macropore Biosurgery, Inc.
Orthopedic · 84d
Cleared Aug 24, 2001
THE SPIN SNAP-OFF SCREW
K011946 · HWC
New Deal, S.A.
Orthopedic · 64d
Cleared Aug 24, 2001
FLEX-NAILS
K012161 · HTY
Fixano SA
Orthopedic · 44d
Cleared Aug 22, 2001
MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM
K012305 · KWQ
Sulzer Spine-Tech
Orthopedic · 30d
Cleared Aug 20, 2001
INTERLOK / HA COPELAND RESURFACING HEADS
K010635 · MBF
Biomet, Inc.
Orthopedic · 171d
Cleared Aug 17, 2001
TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2
K012280 · HWC
Triage Medical, Inc.
Orthopedic · 29d
Cleared Aug 15, 2001
VHS PEDIATRIC HIP SCREW SYSTEM
K011603 · KTT
Walter Abendschein, M.D.
Orthopedic · 83d
Cleared Aug 15, 2001
MODIFICATION TO AEQUALIS SHOULDER SYSTEM
K012212 · KWS
Tornier
Orthopedic · 30d
Cleared Aug 15, 2001
SPIRAL RADIUS 90-D SST SYSTEM
K012273 · MNH
United States Surgical, A Division of...
Orthopedic · 27d
Cleared Aug 15, 2001
MAXIM RPG PS FEMORAL COMPONENT
K012348 · JWH
Biomet, Inc.
Orthopedic · 22d
Cleared Aug 14, 2001
BAUMER LOCKING NAIL
K011504 · JDS
Baumer, S.A
Orthopedic · 90d
Cleared Aug 09, 2001
SYNTHES LCP PROXIMAL TIBIA PLATE
K011978 · HRS
Synthes (Usa)
Orthopedic · 45d
Cleared Aug 07, 2001
WUJIN #3 FEMORAL BONE PLATE
K011459 · HRS
Biopro, Inc.
Orthopedic · 88d
Cleared Aug 07, 2001
WUJIN #3 TIBIAL BONE PLATE
K011460 · HRS
Biopro, Inc.
Orthopedic · 88d
Cleared Aug 07, 2001
SCS CLARIS SPINAL SCREWS, TYPES V,G,E
K011807 · MNI
Ortho Tec, LLC
Orthopedic · 57d
Cleared Aug 03, 2001
KSEA MANHES TAKE-APART BIPOLAR COAGULATING FORCEPS
K010345 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 179d
Cleared Aug 03, 2001
GEO STRUCTURE
K010530 · MQP
Interpore Cross Intl.
Orthopedic · 161d
Cleared Aug 03, 2001
ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM
K011102 · HWC
Aesculap, Inc.
Orthopedic · 114d
Cleared Aug 03, 2001
EBI OSTEOSTIM GRANULES-RESORBABLE BONE GRAFT SUBSTITUTE
K011386 · MQV
Ebi, L.P.
Orthopedic · 88d
Cleared Aug 03, 2001
THREADED CEMENT RESTRICTOR (CR) TITANIUM
K011443 · JDK
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 84d
Cleared Aug 02, 2001
SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM
K011458 · KTW
Synthes (Usa)
Orthopedic · 83d
Cleared Aug 01, 2001
CANNULATED PLUS SCREW SYSTEM
K010738 · HWC
Orthomatrix, Inc.
Orthopedic · 142d
Cleared Aug 01, 2001
ARTHREX BIO-POST AND WASHER
K011495 · MAI
Arthrex, Inc.
Orthopedic · 78d
Cleared Aug 01, 2001
MODIFICATION TO: LONG LENGTH GAMMA NAIL
K012158 · HSB
Howmedica Osteonics Corp.
Orthopedic · 21d