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
14785–14808 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 28, 1995
GDLH POSTERIOR SPINAL SYSTEM
K950596 · MNH
Sofamor Danek USA,Inc.
Orthopedic · 200d
Cleared Aug 25, 1995
SB ANCHOR
K942889 · JDR
Orthopaedic Biosystems, Ltd.
Orthopedic · 431d
Cleared Aug 25, 1995
UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM
K943725 · KWQ
Synthes Spine
Orthopedic · 389d
Cleared Aug 25, 1995
PARAGON POSTERIOR SPINAL SYSTEM
K950955 · MNH
Sofamor Danek USA,Inc.
Orthopedic · 176d
Cleared Aug 25, 1995
EXPANDED RANGE OF SUTURE SIZES OGDEN ANCHORS: 7.4MM AND 5.5MM
K951232 · HWC
American Medical Electronics, Inc.
Orthopedic · 158d
Cleared Aug 25, 1995
LMT BONE ANCHOR
K953764 · JDR
Li Medical Technologies, Inc.
Orthopedic · 14d
Cleared Aug 23, 1995
ACUFEX TAG ANCHOR
K953459 · MBI
Acufex Microsurgical, Inc.
Orthopedic · 30d
Cleared Aug 23, 1995
CO2 ARTHROFLATOR
K953550 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 26d
Cleared Aug 22, 1995
GENESIS II TOTAL KNEE SYSTEM
K951987 · JWH
Smith & Nephew Richards, Inc.
Orthopedic · 117d
Cleared Aug 21, 1995
SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACRAL SCREW FIXATION...
K951626 · MNH
Synthes (Usa)
Orthopedic · 136d
Cleared Aug 21, 1995
VSP (VARIABLE SCREW PLACEMENT) SPINAL FIXATION SYSTEM, PEDICLE SCREW(S),...
K951657 · MNH
Acromed Corp.
Orthopedic · 133d
Cleared Aug 21, 1995
SYNTHES (USA) UNIV. SCREW FIXATION SYSTEM (TITANIUM)
K951794 · MNH
Synthes (Usa)
Orthopedic · 136d
Cleared Aug 21, 1995
OGDEN ANCHOR
K952348 · JDR
American Medical Electronics, Inc.
Orthopedic · 94d
Cleared Aug 21, 1995
HIP FRACTURE STEM FENESTRATION PLUG
K953067 · JDG
Howmedica Corp.
Orthopedic · 52d
Cleared Aug 18, 1995
HOWMEDICA(R) ACETABULAR COMP PACK/MANUF METH CHANGE
K934060 · LPH
Howmedica Corp.
Orthopedic · 729d
Cleared Aug 18, 1995
PACKAGING AND MANUFACTURING METHODS CHANGE/KNEE COMPONENTS
K936292 · LPH
Howmedica Corp.
Orthopedic · 610d
Cleared Aug 18, 1995
POWERGRIP(TM) COMPRESSION FIXATION DEVICE
K950009 · JDW
Synvasive Technology, Inc.
Orthopedic · 227d
Cleared Aug 18, 1995
SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW
K952296 · HWC
Synthes (Usa)
Orthopedic · 94d
Cleared Aug 18, 1995
DEPUY DURALOC 400 ACETABULAR CUP
K952740 · LPH
Depuy, Inc.
Orthopedic · 64d
Cleared Aug 15, 1995
AMD SYSTEM WORKING CHANNEL SCOPE AND ACCESSORIES
K950093 · HRX
Smith & Nephew Richards, Inc.
Orthopedic · 217d
Cleared Aug 14, 1995
OSTEONICS PS HEMI-HIP STEM SERIES
K933882 · LPH
Osteonics Corp.
Orthopedic · 734d
Cleared Aug 14, 1995
DYNA-LOK ANTERIOR PLATING SYSTEM
K936307 · MNH
Danek Group, Inc.
Orthopedic · 721d
Cleared Aug 14, 1995
INTEQ TFCC REPAIR SYSTEM
K941862 · HRX
Linvatec Corp.
Orthopedic · 486d
Cleared Aug 14, 1995
OSTEONICS RESTORATION CEMENTED HIP STEM SERIES
K943778 · KWL
Osteonics Corp.
Orthopedic · 377d