Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

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

Filters: Orthopedic ×
17,985 results
14953–14976 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 09, 1995
HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS
K953510 · KWY
Encore Orthopedics, Inc.
Orthopedic · 14d
Cleared Aug 08, 1995
GENESIS POSTERIOR STABILIZED (P/S) KNEE SYSTEM
K946088 · JWH
Smith & Nephew Richards, Inc.
Orthopedic · 238d
Cleared Aug 08, 1995
STELKAST ALL POLYETHYLENE ACETABULAR CUP
K953169 · LZO
Stelkast Company
Orthopedic · 32d
Cleared Aug 07, 1995
CRADLE FIXATION DEVICE
K941772 · JDR
Neoligaments, Ltd.
Orthopedic · 483d
Cleared Aug 07, 1995
TITANIUM TSRH(R) SPINAL SYSTEM (SCREWS)
K946348 · MNH
Sofamor Danek USA,Inc.
Orthopedic · 220d
Cleared Aug 07, 1995
REPLICA TOTAL HIP SYSTEM
K951741 · LPH
Osteo-Technology Intl., Inc.
Orthopedic · 129d
Cleared Aug 07, 1995
BIOFIX BIOABSORABABLE SELF-REINFORCED POLY-L-LACTIDE, THREADED FIXATION ROD
K952471 · MAI
Bioscience, Inc.
Orthopedic · 73d
Cleared Jul 31, 1995
BIOABSORBABLE INTERFERENCE SCREW
K943249 · MAI
Instrument Makar, Inc.
Orthopedic · 390d
Cleared Jul 31, 1995
GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING)
K950864 · LZJ
Acu Med, Inc.
Orthopedic · 154d
Cleared Jul 31, 1995
SPINE-TECH MODIFIED LAPAROSCOPIC SPINAL FUSION INSTRUMENT SYSTEM
K951268 · HRX
Spine-Tech, Inc.
Orthopedic · 132d
Cleared Jul 31, 1995
TI. ALLOY 2.0 MM CORTEX SCREW
K952272 · HWC
Synthes (Usa)
Orthopedic · 77d
Cleared Jul 31, 1995
CANNULATED PLUS HIP SCREW
K952640 · JDW
Wrightmedicaltechnologyinc
Orthopedic · 52d
Cleared Jul 26, 1995
5.8MM DIAMETER ANCHOR SCREW
K951308 · MNH
Advanced Spine Fixation Systems, Inc.
Orthopedic · 126d
Cleared Jul 26, 1995
ARGUS MEDICAL COMPANY LAPAROSCOPIC DISCECTOMY INSTRUMENT SYSTEM
K951624 · HRX
Argus Medical Co., Inc.
Orthopedic · 110d
Cleared Jul 25, 1995
TITANIUM LOW PROFILE CROSS BAR
K951172 · MNH
Advanced Spine Fixation Systems, Inc.
Orthopedic · 132d
Cleared Jul 25, 1995
LACTOSORB POP RIVET
K951658 · JDR
Poly-Medics,Inc.
Orthopedic · 106d
Cleared Jul 24, 1995
REUNION BONE SCREW SYSTEM
K951389 · HWC
Smith & Nephew Richards, Inc.
Orthopedic · 119d
Cleared Jul 21, 1995
DEPUY MOTECH MOSS SPINAL SYSTEM - PEDICLE FIXATION
K950695 · MNH
Depuy Motech
Orthopedic · 157d
Cleared Jul 21, 1995
VITALOCK SOLID BACKED ACETABULAR SHELL
K952397 · LPH
Howmedica Corp.
Orthopedic · 60d
Cleared Jul 20, 1995
SYNTHES (USA) ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
K945700 · KWQ
Synthes (Usa)
Orthopedic · 246d
Cleared Jul 18, 1995
HSS FEMORAL COMPONENTS
K934857 · JDI
Hospital For Special Surgery
Orthopedic · 644d
Cleared Jul 18, 1995
NEXMED CANCELLOUS BONE SCREWS
K951656 · HWC
Nexmed, Inc.
Orthopedic · 99d
Cleared Jul 17, 1995
PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION...
K950178 · LZE
Pharma-Plast Intl. A/S
Orthopedic · 181d
Cleared Jul 17, 1995
DEPUY AMK CO-CR FINNED TIBIAL TRAY
K951027 · JWH
Depuy, Inc.
Orthopedic · 133d