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
15649–15672 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 05, 1993
POLY INSERT 20 DEGREE
K920929 · JDL
Dow Corning Wright
Orthopedic · 432d
Cleared May 05, 1993
INFINITY(R) COLLARLESS/MICROTAPER TROCHANTERIC MOD
K920968 · LZO
Dow Corning Wright
Orthopedic · 429d
Cleared May 05, 1993
HYDROXYLAPATITE INFINITY(R)
K920969 · MEH
Dow Corning Wright
Orthopedic · 429d
Cleared May 05, 1993
SOFT TISSUE EXPANDER
K923381 · HWQ
Acufex Microsurgical, Inc.
Orthopedic · 300d
Cleared May 05, 1993
ACUFEX T-BAR
K925573 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 183d
Cleared May 05, 1993
HARPOON SUTURE ANCHOR
K926037 · JDR
Biomet, Inc.
Orthopedic · 155d
Cleared Apr 30, 1993
FPC HIP STEM COMPONENT
K915391 · JDG
Implantology Corp.
Orthopedic · 518d
Cleared Apr 30, 1993
UFC HIP STEM COMPONENT
K924099 · JDG
Implantology Corp.
Orthopedic · 260d
Cleared Apr 29, 1993
STABILITY HIP STEM WITH POROCOAT
K915787 · JDG
Depuy, Inc.
Orthopedic · 492d
Cleared Apr 27, 1993
ENDOTRAK SYSTEM
K925083 · HRX
Instratek, Inc.
Orthopedic · 202d
Cleared Apr 20, 1993
OMNIFIT ZIRCONIA C-TAPER FEMORAL BEARING HEAD
K925695 · LZO
Osteonics Corp.
Orthopedic · 159d
Cleared Apr 14, 1993
STABILITY HIP FEMORAL COMPONENT
K915594 · JDI
Depuy, Inc.
Orthopedic · 488d
Cleared Apr 14, 1993
INTRINSIC STEM
K923911 · LWJ
Turnkey Intergration USA, Inc.
Orthopedic · 253d
Cleared Apr 14, 1993
ALPHATEC 130 COMPRESSION HIP SCREW
K925500 · HRS
Alphatec Mfg., Inc.
Orthopedic · 166d
Cleared Apr 08, 1993
RMHS MONOLITHIC FEMORAL COMPONENT
K923275 · JDI
Smith & Nephew Richards, Inc.
Orthopedic · 276d
Cleared Apr 08, 1993
ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (CTR)
K924144 · HRX
Davol, Inc.
Orthopedic · 233d
Cleared Apr 08, 1993
DANEK TISSUE RESECTING SYSTEM
K925577 · HRX
Sofamor Danek Mfg., Inc.
Orthopedic · 156d
Cleared Apr 06, 1993
PERFECTA TOTAL HIP SYSTEM
K922847 · JDI
Orthomet, Inc.
Orthopedic · 295d
Cleared Apr 06, 1993
TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE
K926579 · HWC
Techmedica, Inc.
Orthopedic · 133d
Cleared Apr 05, 1993
DANEKSCOPE AND ACCESSORIES
K911729 · HRX
Danek Medical, Inc.
Orthopedic · 719d
Cleared Apr 02, 1993
HIP JOINT PROTHESIS
K921400 · LPH
Smith & Nephew Richards, Inc.
Orthopedic · 374d
Cleared Apr 01, 1993
M3 LAG SCREW FIXATION SYSTEM
K924018 · HWC
Osteomed Corp.
Orthopedic · 233d
Cleared Mar 31, 1993
NATURAL-KNEE ALL-POLY TIBIA
K923443 · JWH
Intermedics Orthopedics
Orthopedic · 261d
Cleared Mar 31, 1993
ACE 8.0MM CANNULATED CANCELLOUS BONE SCREW
K926047 · HWC
Ace Orthopedic Manufacturing Co.
Orthopedic · 120d