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
15049–15072 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
Cleared Jan 27, 1995
EXTERNAL FIXATOR
K943857 · JEC
Acu Med, Inc.
Orthopedic · 172d
Cleared Jan 27, 1995
CONSENUS HIP SYSTEM -- ACETABULAR REAMER
K945186 · HWE
U.S. Medical Products, Inc.
Orthopedic · 95d
Cleared Jan 27, 1995
CONSENSUS HIP SYSTEM -- CALCAR PLANER
K945189 · HWE
U.S. Medical Products, Inc.
Orthopedic · 95d
Cleared Jan 27, 1995
CONSENSUS HIP SYSTEM -- TROCHANTERIC CUTTER
K945208 · HWE
U.S. Medical Products, Inc.
Orthopedic · 94d
Cleared Jan 24, 1995
ARTHROSCOPE
K944842 · HRX
5 Star Medical, Inc.
Orthopedic · 116d
Cleared Jan 24, 1995
DYONICS FIXATION SCREWS
K945182 · HWC
Smith & Nephew Dyonics, Inc.
Orthopedic · 92d
Cleared Jan 20, 1995
TSRH SPINAL SCREWS
K932029 · MNH
Sofamor Danek Mfg., Inc.
Orthopedic · 633d
Cleared Jan 20, 1995
DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM
K943853 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 165d
Cleared Jan 19, 1995
HOWMEDICA STRAIGHT STEM FEMORAL COMPONENT
K940307 · JDI
Howmedica, Inc.
Orthopedic · 360d
Cleared Jan 19, 1995
S.T.E.P. UNI-KNEE
K940389 · HRY
S.T.E.P. Orthopaedics, Inc.
Orthopedic · 358d
Cleared Jan 19, 1995
SENTRY TOTAL HIP
K945089 · LZO
Howmedica Corp.
Orthopedic · 94d
Cleared Jan 19, 1995
HOWMEDICA ZIRCONIA CERAMIC FEMORAL HEAD
K945090 · LZO
Howmedica Corp.
Orthopedic · 94d
Cleared Jan 19, 1995
P.C.A.PRIMARY HIP- CEMENTLESS USE
K945092 · LZO
Howmedica Corp.
Orthopedic · 94d
Cleared Jan 19, 1995
P.C.A. E-SERIES HIP- CEMENTLESS USE
K945093 · LZO
Howmedica, Inc.
Orthopedic · 94d
Cleared Jan 19, 1995
HNR-PC HIP
K945094 · LZO
Howmedica Corp.
Orthopedic · 94d