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
13345–13368 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 25, 1999
FLEXIBLE FIBERSCOPES & ACCESSORIES
K990397 · HRX
Richard Wolf Medical Instruments Corp.
Orthopedic · 258d
Cleared Oct 25, 1999
3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90...
K992837 · KTW
Synthes (Usa)
Orthopedic · 63d
Cleared Oct 25, 1999
HYDROCISION ARTHROJET SYSTEM WITH CAUTERY
K993009 · HRX
Hydrocision, Inc.
Orthopedic · 48d
Cleared Oct 22, 1999
REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS
K991026 · LPH
Smith & Nephew, Inc.
Orthopedic · 207d
Cleared Oct 22, 1999
HOWMEDICA OSTEONICS ACCP SYSTEM CORTICAL SCREWS
K993181 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Oct 21, 1999
BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS
K992899 · KWS
Biomet, Inc.
Orthopedic · 52d
Cleared Oct 15, 1999
BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT
K992394 · HSD
Endotec, Inc.
Orthopedic · 88d
Cleared Oct 14, 1999
CONTOUR SPINAL SYSTEM
K990986 · KWP
Ortho Development Corp.
Orthopedic · 204d
Cleared Oct 14, 1999
RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454
K992458 · MBI
Innovasive Devices, Inc.
Orthopedic · 83d
Cleared Oct 14, 1999
MAXIM KNEE SYSTEM
K993159 · JWH
Biomet, Inc.
Orthopedic · 23d
Cleared Oct 13, 1999
SYNERGY INTEGRAL SCREWS, MODELS,...
K992369 · MNI
Interpore Cross Intl.
Orthopedic · 90d
Cleared Oct 08, 1999
EBI OMEGA 21 SYSTEM
K992333 · MNI
Electro-Biology, Inc.
Orthopedic · 87d
Cleared Oct 08, 1999
RC TACK
K992377 · MBI
Innovasive Devices, Inc.
Orthopedic · 85d
Cleared Oct 08, 1999
THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ
K992409 · JDI
Implex Corp.
Orthopedic · 80d
Cleared Oct 08, 1999
MODIFICATION TO BONE MULCH SCREW SYSTEM
K993025 · HWC
Biomet, Inc.
Orthopedic · 29d
Cleared Oct 08, 1999
HOWMEDICA OSTEONICS RESTORATION HA HIP STEM
K993077 · MEH
Howmedica Osteonics Corp.
Orthopedic · 24d
Cleared Oct 06, 1999
ALTA FULLY THREADED CROSS-LOCKING 5.0 MM SCREW
K993004 · JDS
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Oct 05, 1999
NUVASIVE GUIDED SPINAL ARTHROSCOPY SYSTEM
K990324 · HRX
Nuvasive, Inc.
Orthopedic · 245d
Cleared Oct 05, 1999
NUVASIVE SPINAL ARTHROSCOPE, MODELS 0, 30 AND 70 DEGREES
K992782 · HRX
Nuvasive, Inc.
Orthopedic · 47d
Cleared Oct 05, 1999
ASCENT KNEE SYSTEM
K993111 · JWH
Biomet Manufacturing, Inc.
Orthopedic · 18d
Cleared Oct 01, 1999
MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM
K992276 · MNI
Sulzer Spine-Tech
Orthopedic · 86d
Cleared Sep 24, 1999
AVCORE SYSTEM
K990816 · HWE
Modular Cutting Systems, Inc.
Orthopedic · 197d
Cleared Sep 24, 1999
VAPR 2.3 MM SIDE EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM
K992876 · HRX
Mitek Products
Orthopedic · 29d
Cleared Sep 23, 1999
PE-PLUS ACETABULAR CUP
K992153 · JDI
Plus Orthopedics
Orthopedic · 90d