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
14737–14760 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 16, 1995
SODEM HIGH SPEED SYSTEM
K954080 · HSZ
Sodem Diffusion SA
Orthopedic · 46d
Cleared Oct 12, 1995
DALL-MILES SUTURE/BEADED CABLE
K953818 · JDQ
Howmedica Corp.
Orthopedic · 58d
Cleared Oct 12, 1995
ACE CERVICAL TRACTION HALOZS, TONGS & PINS
K954069 · HAX
Ace Medical Co.
Orthopedic · 43d
Cleared Oct 11, 1995
J.B.S. ANTERIOR SPINE SYSTEM(R)
K950209 · KWQ
J.B.S. (Usa), Inc.
Orthopedic · 265d
Cleared Oct 05, 1995
EXTERNAL FIXATOR
K952330 · JEC
Acu Med, Inc.
Orthopedic · 140d
Cleared Oct 05, 1995
ACUFEX TAG DELIVERY SYSTEM
K953276 · JDR
Acufex Microsurgical, Inc.
Orthopedic · 83d
Cleared Oct 03, 1995
BRYAN POSTERIOR SPINAL FIXATOR (BPSF)
K953416 · MNH
Arcan Orthopaedic Corp.
Orthopedic · 85d
Cleared Sep 29, 1995
INTRAMEDULLARY COMPRESSION ARTHRODESIS (ICA) NAIL
K952923 · HSB
Howmedica Corp.
Orthopedic · 95d
Cleared Sep 29, 1995
ARTHROSCOPIC ELECTROSURGERY SYSTEM (MODIFICATION)
K953659 · HRX
Arthrocare Corp.
Orthopedic · 58d
Cleared Sep 29, 1995
GRASPING FORCEPS, BIOPSY FORCEPS, SCISSORS, PUNCH
K953868 · HRX
Richard Wolf Medical Instruments Corp.
Orthopedic · 43d
Cleared Sep 28, 1995
STRYKER ACL INTERFERENCE SCREW SYSTEM
K952460 · HWC
Stryker Endoscopy
Orthopedic · 125d
Cleared Sep 27, 1995
AEQUALIS SHOULDER SYSTEM FOR TOTAL & HEMISHOULDER APPLICATIONS
K952928 · KWS
Tornier
Orthopedic · 93d
Cleared Sep 27, 1995
BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD
K953045 · LZO
Biologically Oriented Prostheses
Orthopedic · 89d
Cleared Sep 26, 1995
DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY
K930191 · HRX
Sofamor Danek Mfg., Inc.
Orthopedic · 985d
Cleared Sep 26, 1995
GAS PLASMA STERILIZATION
K944538 · HRY
Depuy, Inc.
Orthopedic · 376d
Cleared Sep 26, 1995
HOWMEDICA MAINSTAY ANCHOR
K953531 · JDR
Howmedica Corp.
Orthopedic · 61d
Cleared Sep 21, 1995
WELLS JOHNSON FIXATION SYSTEM
K945500 · JEY
Wells Johnson Co.
Orthopedic · 316d
Cleared Sep 19, 1995
ETHYLENE OXIDE STERILIZATION OF POLYETHYLENE ORTHOPEDIC DEVICES
K952068 · HSX
Zimmer, Inc.
Orthopedic · 140d
Cleared Sep 19, 1995
BUCHALTER FAUSER FEMORAL COMPONENTS
K952686 · LZO
Biomet, Inc.
Orthopedic · 99d
Cleared Sep 18, 1995
UHMWPE COMPONENTS-CHANGE IN PACKAGING
K940743 · KWY
Depuy, Inc.
Orthopedic · 579d
Cleared Sep 18, 1995
PCA(R) MODULAR TOTAL KNEE TIB INSERT DUROCON BASEPLATE
K940861 · JWH
Howmedica Corp.
Orthopedic · 572d
Cleared Sep 15, 1995
ARTHREX SUTURE ANCHOR SCREW SYSTEM
K934327 · MBI
Arthrex, Inc.
Orthopedic · 742d
Cleared Sep 15, 1995
ORTHONAIL
K952739 · HSB
Orthologic Corp.
Orthopedic · 92d
Cleared Sep 15, 1995
OXBORO-MEDICAL PIN COVERS
K952783 · LRN
Oxboro Medical Intl., Inc.
Orthopedic · 88d