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
14353–14376 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 01, 1996
PRESS-FIT FLARED SHELL
K960633 · LWJ
Encore Orthopedics, Inc.
Orthopedic · 230d
Cleared Oct 01, 1996
AURA HIP SYSTEM CEMENTED FEMORAL STEM/CEMENTED LONG FEMORAL STEM
K961304 · JDI
Exactech, Inc.
Orthopedic · 180d
Cleared Oct 01, 1996
MLI MODULAR STAPLE
K962705 · JDR
Medicinelodge, Inc.
Orthopedic · 81d
Cleared Oct 01, 1996
MITEK MICRO ANCHOR
K962793 · JDR
Mitek Products
Orthopedic · 76d
Cleared Oct 01, 1996
SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHER
K962823 · HWC
Synthes (Usa)
Orthopedic · 74d
Cleared Oct 01, 1996
DEPUY GRADED POROSITY AML HIP (1371-03/06-500/1371-43/46-500)
K962923 · LPH
Depuy, Inc.
Orthopedic · 64d
Cleared Oct 01, 1996
TIBIAL INSERT
K963028 · JWH
Encore Orthopedics, Inc.
Orthopedic · 57d
Cleared Oct 01, 1996
TBD
K963077 · HSB
Acu Med, Inc.
Orthopedic · 54d
Cleared Oct 01, 1996
INTERMOORE FRACTURE HIP STEM (MODIFY)
K963155 · LWJ
Intermedics Orthopedics
Orthopedic · 57d
Cleared Sep 25, 1996
EZ-6 PROXIMAL HUMERAL INTERAMEDULLARY ROD SYSTEM
K962552 · HSB
Biodynamic Technologies, Inc.
Orthopedic · 86d
Cleared Sep 25, 1996
SUPRACONDYLAR INTRAMEDULLARY NAIL
K962561 · HSB
Zimmer, Inc.
Orthopedic · 86d
Cleared Sep 25, 1996
J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS,...
K962757 · MNH
J.B.S., S.A.
Orthopedic · 71d
Cleared Sep 23, 1996
KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN
K961522 · HTY
Synvasive Technology, Inc.
Orthopedic · 154d
Cleared Sep 23, 1996
PRIME MODULAR ENDO HEAD
K962646 · KWL
Orthopaedic Innovations, Inc.
Orthopedic · 77d
Cleared Sep 20, 1996
SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME)
K960087 · JDB
Wrightmedicaltechnologyinc
Orthopedic · 253d
Cleared Sep 20, 1996
SCARF THREAD-HEAD SCREW
K962236 · HWC
Landos, Inc.
Orthopedic · 101d
Cleared Sep 19, 1996
PRIMALOC CEMENTED HIP SYSTEM
K962448 · KWY
Ortho Development Corp.
Orthopedic · 87d
Cleared Sep 19, 1996
VITALITY HIP STEM
K962560 · JDI
Encore Orthopedics, Inc.
Orthopedic · 80d
Cleared Sep 17, 1996
OMEGA TOTAL HIP SYSTEM FOR CEMENTED APPLICATIONS
K960647 · JDI
Osteoimplant Technology, Inc.
Orthopedic · 215d
Cleared Sep 17, 1996
SHP HIP SYSTEM-FEMORAL COMPONENTS/ACETABULAR COMPONENTS/MODULAR...
K960984 · JDI
Biomet, Inc.
Orthopedic · 190d
Cleared Sep 17, 1996
DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM
K961186 · LPH
Depuy, Inc.
Orthopedic · 175d
Cleared Sep 17, 1996
PRESS-FIT POROUS SHELL
K961526 · LPH
Encore Orthopedics, Inc.
Orthopedic · 148d
Cleared Sep 17, 1996
VERSALOK SCREW ASSEMBLY (PROPOSED NAME)
K961572 · MNH
Wrightmedicaltechnologyinc
Orthopedic · 147d
Cleared Sep 17, 1996
CROSS PIN
K961920 · JDW
Medicinelodge, Inc.
Orthopedic · 123d