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
14809–14832 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 14, 1995
S-ROM NOILES POSTERIOR STABILIZED TOTAL KNEE SYSTEM II
K944321 · JWH
Joint Medical Products Corp.
Orthopedic · 346d
Cleared Aug 11, 1995
WRIGHT-LOC(TM) SPINAL FIXATION SYSTEM
K950074 · MNH
Wrightmedicaltechnologyinc
Orthopedic · 214d
Cleared Aug 11, 1995
ACROMED PEDICLE SCREW
K951116 · MNH
Acromed Corp.
Orthopedic · 154d
Cleared Aug 11, 1995
INTRAMEDULARY FIXATION ROD
K951740 · HSB
Acu Med, Inc.
Orthopedic · 140d
Cleared Aug 11, 1995
OSTEONICS SERIES 7000 TOTAL KNEE FULL TIBIAL BONE AUGEMENTATION BLOCKS & WEDGES
K951956 · JWH
Osteonics Corp.
Orthopedic · 107d
Cleared Aug 09, 1995
DURACON BASEPLATES
K936008 · JWH
Howmedica Corp.
Orthopedic · 601d
Cleared Aug 09, 1995
OSTEONICS RESTORATION MONOLITHIC HIP STEM
K951291 · MEH
Osteonics Corp.
Orthopedic · 156d
Cleared Aug 09, 1995
STRICKLAND TRAPEZIAL IMPLANT
K951471 · KYI
Wrightmedicaltechnologyinc
Orthopedic · 132d
Cleared Aug 09, 1995
ECTRA LIGAMENT RELEASE SYSTEM
K953387 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 21d
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