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
13729–13752 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 20, 1998
INTEGRATED DRIVE/PUMP SYSTEM
K981636 · HRX
Linvatec Corp.
Orthopedic · 104d
Cleared Aug 11, 1998
MYELOTEC VIDEO GUIDED CATHETER
K980734 · HRX
Myelotec, Inc.
Orthopedic · 167d
Cleared Aug 11, 1998
RETROGRADE PEDIATRIC NAIL
K980854 · HTY
Encore Orthopedics, Inc.
Orthopedic · 159d
Cleared Aug 11, 1998
BIOMET 100% POROUS COATED BIAXIAL TOTAL ELBOW
K982398 · JDC
Biomet, Inc.
Orthopedic · 32d
Cleared Aug 10, 1998
PRINCE MEDICAL CEMENT PLUG
K981855 · JDI
Prince Medical, Inc.
Orthopedic · 76d
Cleared Aug 07, 1998
MODIFICATION TO TOWNLEY PEDICLE SCREW PLATING SYSTEM
K982686 · MNI
Sofamor Danek USA,Inc.
Orthopedic · 4d
Cleared Aug 06, 1998
5.0MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22255, 3.5MM PARACHUTE...
K974847 · MBI
Arthrex, Inc.
Orthopedic · 220d
Cleared Aug 06, 1998
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K982011 · KWP
DePuy Orthopaedics, Inc.
Orthopedic · 59d
Cleared Aug 04, 1998
SYNTHES SPINE PEDIATRIC ROD SYSTEM
K980761 · MNH
Synthes Spine
Orthopedic · 158d
Cleared Jul 31, 1998
IMPLEX CONTINUUM KNEE - HEDROCEL TIBIAL SPACERS
K982302 · JWH
Implex Corp.
Orthopedic · 30d
Cleared Jul 30, 1998
MACROPORE PROTECTIVE SHEET (PROTEGO SYSTEM)
K972913 · HRS
Pacific Materials and Interfaces
Orthopedic · 357d
Cleared Jul 29, 1998
SPINE-TECH SILHOUETTE SPINAL FIXATION SYSTEM
K980288 · KWP
Spine-Tech, Inc.
Orthopedic · 184d
Cleared Jul 29, 1998
DISTAL RADIUS FRACTURE FIXATION PLATE
K981715 · HRS
Avanta Orthopaedics, Inc.
Orthopedic · 75d
Cleared Jul 29, 1998
DEPUY ACE TIMAX CALCANEAL PERI-ARTICULAR PLATE
K981775 · HRS
Depuy Ace Medical Co.
Orthopedic · 70d
Cleared Jul 29, 1998
SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM
K982222 · HWC
Synthes (Usa)
Orthopedic · 35d
Cleared Jul 29, 1998
DOC VENTRAL CERVICAL STABILIZATION SYSTEM
K982443 · KWQ
Depuy Motech Acromed
Orthopedic · 15d
Cleared Jul 27, 1998
MENISCAL REPAIR DEVICE
K981692 · MBI
Linvatec Corp.
Orthopedic · 75d
Cleared Jul 17, 1998
EXTERNAL FIXATION
K981716 · JDW
Avanta Orthopaedics, Inc.
Orthopedic · 63d
Cleared Jul 17, 1998
SYNTHES (USA) DHS HELIX SYSTEM
K981757 · JDO
Synthes (Usa)
Orthopedic · 59d
Cleared Jul 17, 1998
BIOLOX ALUMINA CERAMIC FEMORAL HEAD
K981847 · LZO
Smith & Nephew, Inc.
Orthopedic · 52d
Cleared Jul 17, 1998
WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW...
K981967 · MBI
Arthrotek/Biomet, Inc.
Orthopedic · 43d
Cleared Jul 13, 1998
HOWMEDICA MODULAR REPLACEMENT SYSTEM - DISTAL FEMORAL/PROXIMAL TIBIAL SEGMENTS
K972401 · KRO
Howmedica Corp.
Orthopedic · 382d
Cleared Jul 13, 1998
DEPUY GLOBAL SHOULDER GLENOID
K981487 · KWS
DePuy Orthopaedics, Inc.
Orthopedic · 77d
Cleared Jul 13, 1998
ANSPACH SUTURE ANCHOR
K981688 · MBI
The Anspach Effort, Inc.
Orthopedic · 63d