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
12241–12264 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Sep 17, 2002
BIOMET CALCANEAL PLATE
K022515 · HRS
Biomet Orthopedics, Inc.
Orthopedic · 49d
Cleared Sep 13, 2002
NORMED DISTAL RADIUS RECONSTRUCTION SYSTEM
K022231 · HRS
Osteomedics, Inc.
Orthopedic · 65d
Cleared Sep 10, 2002
UCR SPINAL SYSTEM, 5.5MM, 8.0MM SCREWS & INSTRUMENTS
K021623 · MNH
Iame, Inc.
Orthopedic · 117d
Cleared Sep 10, 2002
NORMED MINI EXTERNAL FIXATOR SYSTEM
K022230 · HRS
Osteomedics, Inc.
Orthopedic · 62d
Cleared Sep 09, 2002
NORMED TITANIUM RONDO FIX FUSION PLATES AND SCREW SYSTEM
K022323 · HRS
Osteomedics, Inc.
Orthopedic · 54d
Cleared Sep 09, 2002
NORMED TITANIUM OSTEOTOMY PLATING SYSTEM
K022325 · HRS
Osteomedics, Inc.
Orthopedic · 54d
Cleared Sep 06, 2002
CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER
K011531 · MQV
Biomet, Inc.
Orthopedic · 477d
Cleared Sep 06, 2002
ARTHREX UNIVERS FRACTURE PROSTHESIS
K020345 · KWS
Arthrex, Inc.
Orthopedic · 217d
Cleared Sep 06, 2002
SYNTHES 6.5 MM CANNULATED SCREW
K021932 · HWC
Synthes (Usa)
Orthopedic · 86d
Cleared Sep 06, 2002
STAYFUSE GT-IP
K022726 · HWC
Pioneer Surgical Technology
Orthopedic · 21d
Cleared Sep 05, 2002
ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM
K021891 · LPH
Zimmer, Inc.
Orthopedic · 90d
Cleared Sep 05, 2002
HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, MODEL 7.3MM
K022647 · HWC
Triad Medical, Inc.
Orthopedic · 27d
Cleared Aug 30, 2002
HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1
K022563 · MQP
Implex Corp.
Orthopedic · 28d
Cleared Aug 28, 2002
MODIFICATION TO TENOR SPINAL SYSTEM
K022191 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 54d
Cleared Aug 28, 2002
REFLECTION MODIFIED ACETABULAR SHELLS
K022556 · LPH
Smith & Nephew, Inc.
Orthopedic · 26d
Cleared Aug 27, 2002
5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM)
K022623 · KWP
Depuyacromed
Orthopedic · 20d
Cleared Aug 26, 2002
BNF
K021782 · JDS
Aap Implantate AG
Orthopedic · 88d
Cleared Aug 26, 2002
TITANIUM ANKLE ARTHRODESIS NAIL
K021786 · HSB
Biomet, Inc.
Orthopedic · 88d
Cleared Aug 26, 2002
VERTE-STACK SPINAL SYSTEM
K021791 · MQP
Medtronic Sofamor Danek
Orthopedic · 87d
Cleared Aug 26, 2002
TEMPFIX EXTERNAL FIXATION SYSTEM
K021933 · KTT
DePuy Orthopaedics, Inc.
Orthopedic · 75d
Cleared Aug 26, 2002
S2 TIBIAL NAIL
K022481 · HSB
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Aug 26, 2002
2MM PEDIATRIC FLEX NAIL
K022531 · HTY
Biomet, Inc.
Orthopedic · 26d
Cleared Aug 26, 2002
ACCOLADE C FEMORAL STEMS
K022555 · LZO
Howmedica Osteonics Corp.
Orthopedic · 24d
Cleared Aug 26, 2002
MODIFICATION TO AVALON CUP SYSTEM
K022711 · LPH
Orthopedic Source, Inc.
Orthopedic · 12d