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
15985–16008 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 11, 1991
NATURAL POROUS HIP SYSTEM
K913060 · JDI
Intermedics Orthopedics
Orthopedic · 93d
Cleared Oct 11, 1991
KINEMAX PLUS TIBIAL INSERT
K913188 · JWH
Howmedica Corp.
Orthopedic · 85d
Cleared Oct 11, 1991
APR II NON-POROUS HIP STEM
K913208 · JDI
Intermedics Orthopedics
Orthopedic · 84d
Cleared Oct 10, 1991
ARTHRO-FLOW IRRIGATION 2 SYSTEM
K913028 · HRX
Davol, Inc.
Orthopedic · 93d
Cleared Oct 04, 1991
SIMMONS PLATING SYSTEM
K910681 · KWQ
Smith & Nephew Richards, Inc.
Orthopedic · 231d
Cleared Oct 04, 1991
AMSET(TM) BONE SCREW
K911768 · HWC
Advanced Med/Surg, Inc.
Orthopedic · 168d
Cleared Oct 04, 1991
HA MCCUTCHEN SLT HIP SYSTEM
K912452 · MEH
Dow Corning Wright
Orthopedic · 123d
Cleared Oct 04, 1991
DIMENSION-HA HIP PROSTHESIS
K912922 · MEH
Kirschner Medical Corp.
Orthopedic · 93d
Cleared Oct 04, 1991
CONCEPT MICROMILL
K912957 · HRX
Concept, Inc.
Orthopedic · 88d
Cleared Oct 04, 1991
FIXATION DEVICES AND BONE PLATE
K913930 · HRS
John M. Rayhack
Orthopedic · 43d
Cleared Oct 03, 1991
ITM SONIC SURGERY SYSTEM
K912931 · JDX
Buckman Co., Inc.
Orthopedic · 90d
Cleared Oct 02, 1991
MODULAR HIP SYSTEM
K912593 · JDI
Smith & Nephew Richards, Inc.
Orthopedic · 114d
Cleared Sep 27, 1991
APR COLLAR SPACER
K912916 · JDI
Intermedics Orthopedics
Orthopedic · 86d
Cleared Sep 25, 1991
SYNTHES MAXILLOFACIAL TITANIUM MICRO SET
K912932 · HRS
Synthes (Usa)
Orthopedic · 82d
Cleared Sep 24, 1991
OPTICAL CATHETER ARTHROSCOPE
K911296 · HRX
Medical Dynamics, Inc.
Orthopedic · 183d
Cleared Sep 24, 1991
FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE
K912843 · HXB
Flexmedics
Orthopedic · 90d
Cleared Sep 23, 1991
G-PIN
K911375 · HTY
Dr.M.A.Galluzzo
Orthopedic · 179d
Cleared Sep 23, 1991
ORTHOFIX UNREAMED TIBIAL NAIL SYSTEM
K912420 · HSB
Scientific Research
Orthopedic · 115d
Cleared Sep 18, 1991
PALMER ARCH SUPPRESSOR
K913347 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 54d
Cleared Sep 16, 1991
NATURAL-KNEE ULTRA CONGRUENT TIBIAL INSERT
K912663 · JWH
Intermedics Orthopedics
Orthopedic · 90d
Cleared Sep 11, 1991
DANEK SACRAL HOOK, MODIFICATION
K911379 · KWP
Danek Medical, Inc.
Orthopedic · 168d
Cleared Sep 10, 1991
ANATOMIC MODULAR KNEE POLYETHYLENE TIBIAL TRAY
K910940 · JWH
Depuy, Inc.
Orthopedic · 188d
Cleared Sep 10, 1991
T-BOLT AND NUT
K911306 · HTN
Danek Medical, Inc.
Orthopedic · 169d
Cleared Sep 06, 1991
TSRH OPEN HEAD BONE SCREW
K911319 · KWP
Danek Medical, Inc.
Orthopedic · 164d