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
12697–12720 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
Cleared Aug 01, 2001
MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR
K012255 · JDK
Medtronic Sofamor Danek, Inc.
Orthopedic · 14d
Cleared Jul 31, 2001
HIGH TIBIAL OSTEOTOMY PLATING SYSTEM
K011354 · HRS
Dj Orthopedics, LLC
Orthopedic · 89d
Cleared Jul 31, 2001
SUMMIT DUOFIX HIP PROSTHESIS
K011489 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 77d
Cleared Jul 31, 2001
RESORBABLE BONE PINS
K011522 · HTY
Biomet, Inc.
Orthopedic · 75d
Cleared Jul 31, 2001
PASS SPINAL SYSTEM
K012175 · MNI
Encore Orthopedics, Inc.
Orthopedic · 19d
Cleared Jul 31, 2001
OPTETRAK TOTAL KNEE SYSTEM, STRAIGHT STEM EXTENSIONS - ADDITIONAL SIZES
K012251 · JWH
Exactech, Inc.
Orthopedic · 13d
Cleared Jul 27, 2001
SYNTHES CURVED RECONSTRUCTION PLATE
K011334 · HRS
Synthes (Usa)
Orthopedic · 86d
Cleared Jul 27, 2001
SYNTHS ONE-THIRD TUBULAR DCL PLATE
K011335 · HRS
Synthes (Usa)
Orthopedic · 86d
Cleared Jul 26, 2001
METRONIC SOFAMOR DANEK CEMENT RESTRICTOR
K011998 · JDK
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d
Cleared Jul 26, 2001
THE LPS - CONTINUUM TM HYBRID TIBIA, MODELS 32-5886-2Y-XX (ZIMMER) AND...
K012095 · JWH
Implex Corp.
Orthopedic · 21d
Cleared Jul 25, 2001
EBI XFIX DFS SYSTEM
K012024 · KTT
Ebi, L.P.
Orthopedic · 27d
Cleared Jul 23, 2001
TRI-FIX SPINAL FIXATION SYSTEM
K011830 · KWP
Endius, Inc.
Orthopedic · 41d
Cleared Jul 20, 2001
ARTHROSCOPES
K003831 · HRX
Global Endoscopy, Inc.
Orthopedic · 221d
Cleared Jul 20, 2001
MACROPORE OS SPINAL SYSTEM
K010911 · KWQ
Macropore Biosurgery, Inc.
Orthopedic · 116d
Cleared Jul 20, 2001
NORMED EXTREMITY TITANIUM HAND AND SMALL FRAGMENT SYSTEM
K011118 · HRS
Osteomedics
Orthopedic · 99d