FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Orthopedic ×
17,985 results
13873–13896 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
Cleared Jul 13, 1998
LM ANCHOR
K981755 · MBI
Li Medical Technologies, Inc.
Orthopedic · 56d
Cleared Jul 13, 1998
LM ANCHOR
K981764 · MBI
Li Medical Technologies, Inc.
Orthopedic · 55d
Cleared Jul 13, 1998
LORENZ PECTUS SUPPORT BAR STABILIZER
K981789 · HRS
Walter Lorenz Surgical, Inc.
Orthopedic · 54d
Cleared Jul 13, 1998
LACTOSORB POP RIVET
K981798 · JDR
Biomet, Inc.
Orthopedic · 53d
Cleared Jul 13, 1998
MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM
K982154 · MNI
Danek Medical, Inc.
Orthopedic · 24d
Cleared Jul 09, 1998
TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW
K981529 · JDS
Smith & Nephew, Inc.
Orthopedic · 71d
Cleared Jul 09, 1998
OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES,...
K982032 · MEH
Osteonics Corp.
Orthopedic · 29d
Cleared Jul 08, 1998
EBI DFS JOINT FIXATOR, MODEL 02800
K981483 · KTT
Electro-Biology, Inc.
Orthopedic · 75d
Cleared Jul 02, 1998
KYPHON INFLATABLE BONE TAMP
K981251 · HRX
Kyphon, Inc.
Orthopedic · 87d