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
13393–13416 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 27, 1999
OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEM
K991055 · MNH
Howmedica Osteonics Corp.
Orthopedic · 150d
Cleared Aug 27, 1999
SYNTHES CERVIFIX SYSTEM
K991089 · KWP
Synthes Spine
Orthopedic · 149d
Cleared Aug 27, 1999
DYNA-LOK PLUS SPINAL SYSTEM
K991198 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 141d
Cleared Aug 27, 1999
ANATOMICAL BANKART TACK, MODEL 523520A
K992567 · MAI
Bionx Implants, Ltd.
Orthopedic · 25d
Cleared Aug 26, 1999
OSTEOPLAST, MODEL POP200
K991854 · MQV
Interpore Cross Intl.
Orthopedic · 86d
Cleared Aug 23, 1999
AEQUALIS SHOULDER PROSTHESIS
K980244 · KWS
Tornier
Orthopedic · 577d
Cleared Aug 19, 1999
EBI XFIX DFS RAIL SYSTEM
K991941 · KTT
Electro-Biology, Inc.
Orthopedic · 71d
Cleared Aug 19, 1999
B2C HIP SYSTEM
K992490 · JDI
Lepine Groupe Spa.
Orthopedic · 24d
Cleared Aug 18, 1999
BIPOLAR SHOULDER PROSTHESIS
K991585 · KWT
Biomet, Inc.
Orthopedic · 103d
Cleared Aug 17, 1999
MAXIM REMOVABLE MOLDED POLY TIBIA
K991753 · JWH
Biomet, Inc.
Orthopedic · 85d
Cleared Aug 17, 1999
KMI WRIST FUSION SYSTEM
K991873 · HRS
Kinetikos Medical, Inc.
Orthopedic · 76d
Cleared Aug 17, 1999
EBI XFIX DFS OPTIROM ELBOW FIXATOR
K992515 · KTT
Ebi, L.P.
Orthopedic · 20d
Cleared Aug 13, 1999
ARTHREX MENISCAL DART SYSTEM
K983577 · MAI
Arthrex, Inc.
Orthopedic · 304d
Cleared Aug 13, 1999
EBI OMEGA 21 SYSTEM
K991721 · MNI
Ebi Electro Biology
Orthopedic · 85d
Cleared Aug 13, 1999
ENDOSCOPIC SPINAL ACCESS SYSTEM
K991794 · HRX
Endius, Inc.
Orthopedic · 79d
Cleared Aug 13, 1999
PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATING
K992025 · MEH
Howmedica Osteonics Corp.
Orthopedic · 58d
Cleared Aug 13, 1999
OSTEONICS UNIVERSAL DISTAL CEMENT PLUG
K992462 · LZN
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Aug 12, 1999
RIWO DRIVE GENERATOR
K984304 · HRX
Richard Wolf Medical Instruments Corp.
Orthopedic · 253d
Cleared Aug 12, 1999
WHITESIDE BIOMECHANICS SPINAL SYSTEM
K991678 · KWQ
Whiteside Biomechanics, Inc.
Orthopedic · 87d
Cleared Aug 12, 1999
ULTIMAX HAIG II NAIL SYSTEM
K991889 · LXT
Encore Orthopedics, Inc.
Orthopedic · 70d
Cleared Aug 12, 1999
ENCORE FULLY COATED HIP
K992109 · LPH
Encore Orthopedics, Inc.
Orthopedic · 51d
Cleared Aug 12, 1999
KINEMATIC II ROTATING HINGE KNEE
K992346 · LGE
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Aug 06, 1999
HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA)...
K990666 · MEH
Smith & Nephew, Inc.
Orthopedic · 157d
Cleared Aug 06, 1999
BIOSTINGER-V BIOABSORBABLE MENISCAL REPAIR DEVICE
K991715 · MAI
Linvatec Corp.
Orthopedic · 78d