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
16609–16632 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 10, 1988
SHOULDER MICROSTRUCTURED HUMERAL PROSTHESIS
K883816 · KWS
Osteonics Corp.
Orthopedic · 63d
Cleared Nov 09, 1988
CONCEPT POWER SYSTEM
K881954 · HSZ
Concept, Inc.
Orthopedic · 183d
Cleared Nov 09, 1988
KIRSCHNER TC-IV/NON POR COAT/TOTAL CONDYLAR KNEE S
K883215 · JWH
Kirschner Medical Corp.
Orthopedic · 103d
Cleared Nov 01, 1988
IRRIGATION SET
K883300 · HRX
Edwards Orthopaedics Div., Baxter...
Orthopedic · 89d
Cleared Oct 20, 1988
JOHNSON & JOHNSON MODULAR TOTAL KNEE PROSTHESIS
K882234 · JWH
Johnson & Johnson Professionals, Inc.
Orthopedic · 146d
Cleared Oct 20, 1988
SAMUELSON SCREWLOC CUP
K882671 · KWA
Protek, Inc.
Orthopedic · 114d
Cleared Oct 14, 1988
TOWNLEY COX COMB ACETABULAR COMPONENT
K882869 · JDI
Biopro, Inc.
Orthopedic · 95d
Cleared Oct 13, 1988
CASF CANCELLOUS BONE SCREW, BT650
K882934 · HWC
Terray Manufacturing, Inc.
Orthopedic · 92d
Cleared Oct 13, 1988
ARTHRO-TRAC(TM)
K883361 · HRX
Rudolph Beaver, Inc.
Orthopedic · 65d
Cleared Oct 13, 1988
OMNIFIT THREADED ACETABULAR COMP. W/MICRO COATING
K883921 · LWJ
Osteonics Corp.
Orthopedic · 27d
Cleared Oct 12, 1988
PCA MODULAR TOTAL KNEE-UNIVERSAL TIBIAL BASEPLATE
K874923 · JWH
Howmedica Corp.
Orthopedic · 314d
Cleared Oct 12, 1988
TRACER BONE MILL
K883183 · LYS
De Medica Mfg., Inc.
Orthopedic · 76d
Cleared Oct 12, 1988
ACUFEX INTERFERENCE SCREW AND SCREWDRIVER
K883910 · HWC
Acufex Microsurgical, Inc.
Orthopedic · 27d
Cleared Oct 11, 1988
FOCUS TOTAL HIP SYSTEM
K883460 · JDI
Depuy, Inc.
Orthopedic · 57d
Cleared Oct 11, 1988
TECNOL BUCKS TRACTION W/HEEL PROTECTOR
K884132 · KQZ
Technol, Inc.
Orthopedic · 11d
Cleared Oct 06, 1988
HOWMEDICA PRECISION OSTEOLOCK FEMORAL COMPONENT
K881983 · LWJ
Howmedica Corp.
Orthopedic · 147d
Cleared Sep 30, 1988
JMS CERVICAL TRACTION DEVICE/HALO DEVICE
K882877 · JEC
Jerome Medical
Orthopedic · 81d
Cleared Sep 30, 1988
BONE FIXATION WIRE
K882967 · JDQ
Baxter Healthcare Corp
Orthopedic · 77d
Cleared Sep 30, 1988
HORIZON ORTHOPEDIC PIN PROTECTOR
K883576 · LYT
Horizon Medical, Inc.
Orthopedic · 39d
Cleared Sep 23, 1988
CASF DRILL GUIDE DG 170
K882871 · LYQ
Terray Manufacturing, Inc.
Orthopedic · 74d
Cleared Sep 22, 1988
SPINAL MICROKNIFE
K882525 · HTS
Karlin Technology, Inc.
Orthopedic · 97d
Cleared Sep 22, 1988
TECHMEDICA MP SYSTEM
K882922 · KTT
Techmedica, Inc.
Orthopedic · 71d
Cleared Sep 22, 1988
HIP FRACTURE STEM SYSTEM
K883179 · KWL
Howmedica Corp.
Orthopedic · 57d
Cleared Sep 22, 1988
AXIAL COMPRESSION SCREW
K883715 · KTT
Straub Clinic and Hospital
Orthopedic · 22d