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
14905–14928 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Sep 08, 1995
NEXFLEX TOTAL HIP SYSTEM
K952629 · JDI
Nexmed, Inc.
Orthopedic · 92d
Cleared Sep 08, 1995
DISPOSABLE BIOPSY FORCEP
K952630 · HRX
Neuro Navigational Corp.
Orthopedic · 92d
Cleared Sep 08, 1995
DISPOSABLE TOOTHED GRASPING FORCEP
K952639 · HRX
Neuro Navigational Corp.
Orthopedic · 91d
Cleared Sep 08, 1995
HOFFMANN II EXTERNAL FIXATION SYSTEM
K952730 · JEC
Howmedica Corp.
Orthopedic · 85d
Cleared Sep 08, 1995
SLT 28MM XXL FEMORAL HEAD
K953025 · JDI
Wrightmedicaltechnologyinc
Orthopedic · 71d
Cleared Sep 08, 1995
STAINLESS STEEL VARIFIX SYSTEM 5.0MM DIAMETER ANCHOR SCREW
K953369 · MNH
Advanced Spine Fixation Systems, Inc.
Orthopedic · 52d
Cleared Sep 06, 1995
OSTEONICS RESTORATION MONOLITHIC II SLOTTED HIP STEM SERIES
K951671 · MEH
Osteonics Corp.
Orthopedic · 148d
Cleared Sep 01, 1995
MICRO-ARTHROSCOPE
K930084 · HRX
Medical Devices, Inc.
Orthopedic · 967d
Cleared Sep 01, 1995
STRYKER PRESSURE SENSING CANNULA
K944593 · HRX
Stryker Endoscopy
Orthopedic · 347d
Cleared Sep 01, 1995
ROGOZINSKI SPINAL ROD SYSTEM ROD-TO-BOLT (UNIVERSAL) CONNECTOR FOR USE WITH...
K950865 · MNH
Smith & Nephew Richards, Inc.
Orthopedic · 186d
Cleared Sep 01, 1995
STRYKER UNIVERSAL ACL INSTRUMENTATION SYSTEM
K951267 · HRX
Stryker Endoscopy
Orthopedic · 164d
Cleared Sep 01, 1995
OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES
K951932 · MEH
Osteonics Corp.
Orthopedic · 129d
Cleared Sep 01, 1995
UNIMAT PUMP
K953075 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 63d
Cleared Sep 01, 1995
POLLUX OA/POLLUX 30A/POLLUX 70A
K953484 · HRX
Pollux Endoscopy, Inc.
Orthopedic · 38d
Cleared Aug 29, 1995
KIRSCHNER(R) MODULAR II-C(TM) TOTAL SHOULDER SYSTEM
K940537 · KWT
Kirschner Medical Corp.
Orthopedic · 568d
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