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
15169–15192 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 09, 1995
EXACTECH CRUCIATE RETAINING CEMENTED TOTAL KNEE SY
K932690 · JWH
Exactech, Inc.
Orthopedic · 616d
Cleared Feb 09, 1995
ACUFEX TAG ANCHOR
K934867 · JDR
Acufex Microsurgical, Inc.
Orthopedic · 485d
Cleared Feb 09, 1995
OGDEN ANCHOR-SMALL (TENTATIVE)
K941029 · JDR
American Medical Electronics, Inc.
Orthopedic · 339d
Cleared Feb 09, 1995
ISOLA ANTERIOR SYSTEM
K943819 · KWQ
Acromed Corp.
Orthopedic · 188d
Cleared Feb 08, 1995
APOLLO KNEE TIBIAL BASEPLATE/KNEE TIBIAL INSERT
K934381 · JWH
Intermedics Orthopedics
Orthopedic · 518d
Cleared Feb 08, 1995
FOUNDATION KNEE AUGMENTATION BLOCKS
K941306 · JWH
Encore Orthopedics, Inc.
Orthopedic · 328d
Cleared Feb 08, 1995
EBI ANTERIOR CERVICAL SPINE SYSTEM
K943694 · KWQ
Electro-Biology, Inc.
Orthopedic · 194d
Cleared Feb 06, 1995
POSTERIOR STABILIZED APOLLO KNEE SYSTEM
K935789 · JWH
Intermedics Orthopedics
Orthopedic · 427d
Cleared Feb 06, 1995
UNIVERSAL WRIST
K940297 · JWI
Turnkey Intergration USA, Inc.
Orthopedic · 381d
Cleared Feb 03, 1995
AIMS CANNULATED ACL SCREW (7MM DIAMETER)
K945236 · HWC
Smith and Nephew Donjoy, Inc.
Orthopedic · 99d
Cleared Feb 02, 1995
BONE MULCH SCREW
K941941 · HWC
Biomet, Inc.
Orthopedic · 287d
Cleared Feb 01, 1995
AME UNIVERSAL FIXATION SYSTEM
K931381 · KWP
American Medical Electronics, Inc.
Orthopedic · 685d
Cleared Feb 01, 1995
KNEE PROTHESIS
K941769 · JWH
Joint Medical Products Corp.
Orthopedic · 296d
Cleared Feb 01, 1995
ARTHROSCOPE,RIGID ROD-LENS DIAGNOSTIC ENDOSCOPE
K943426 · HRX
Schoelly Technologies, Inc.
Orthopedic · 201d
Cleared Feb 01, 1995
ARTHREX STAPLES
K943492 · JDR
Arthrex, Inc.
Orthopedic · 197d
Cleared Feb 01, 1995
INNOVASIVE 1.9MM, 2.8MM, 3.5MM, 4.5MM ROC SUTURE BONE FASTENER
K944831 · MBI
Innovasive Devices, Inc.
Orthopedic · 125d
Cleared Feb 01, 1995
CONSENUS HIP SYSTEM FEMORAL CANAL STARTER REAMER
K944946 · HWE
U.S. Medical Products, Inc.
Orthopedic · 117d
Cleared Feb 01, 1995
PEDIATRIC OSTEOTOMY SYSTEM
K945233 · KTT
Howmedica Corp.
Orthopedic · 121d
Cleared Jan 30, 1995
NEXT GENERATION KNEE SYSTEM
K933785 · JWH
Zimmer, Inc.
Orthopedic · 544d
Cleared Jan 30, 1995
OGDEN ANCHOR ADDITIONAL APPLICATIONS
K935065 · JDR
American Medical Electronics, Inc.
Orthopedic · 467d
Cleared Jan 30, 1995
OSTEONICS(R) SERIES 7000 TOTAL KNEE
K940813 · JWH
Osteonics Corp.
Orthopedic · 342d
Cleared Jan 27, 1995
APOLLO KNEE FEMORAL COMPONENT
K933229 · JWH
Intermedics Orthopedics
Orthopedic · 574d
Cleared Jan 27, 1995
TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION
K933995 · HSB
Applied Osteo Systems, Inc.
Orthopedic · 528d
Cleared Jan 27, 1995
DEPUY AMK ALL POLYETHYLENE POSTERIOR STABLILIZED TIBIAL TRAY
K943299 · JWH
Depuy, Inc.
Orthopedic · 202d