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
15913–15936 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 22, 1992
TSRH VARIABLE ANGLE SACRAL SCREW
K904243 · KWP
Danek Medical, Inc.
Orthopedic · 495d
Cleared Jan 21, 1992
RIHARDS TITANIUM HALF PIN
K920024 · KTT
Smith & Nephew Richards, Inc.
Orthopedic · 19d
Cleared Jan 17, 1992
TRUE/FLEX HUMERUS, ULNA & RADIUS INTRAMED RODS SYS
K913949 · HSB
Applied Osteo Systems, Inc.
Orthopedic · 130d
Cleared Jan 17, 1992
SYNTHES(R) TITANIUM SMALL RECONSTRUCTION PLATE
K915818 · HRS
Synthes (Usa)
Orthopedic · 18d
Cleared Jan 16, 1992
HOFFMANN DYNAMIC WRIST FIXATOR
K910986 · KTT
Howmedica Corp.
Orthopedic · 315d
Cleared Jan 16, 1992
ZIRCONIA CERAMIC MODULAR HEADS(TYPE I TAPER) MODIF
K913420 · LZO
Biomet, Inc.
Orthopedic · 175d
Cleared Jan 16, 1992
LUQUE SEGMENTAL SPINAL INSTRUMENTATION
K913561 · KWP
Zimmer, Inc.
Orthopedic · 160d
Cleared Jan 16, 1992
TRAUMAFIX (TM) EXTERNAL FIXATOR
K914558 · KTT
Synthes (Usa)
Orthopedic · 93d
Cleared Jan 16, 1992
GLOBAL TOTAL SHOULDER
K914695 · KWT
Depuy, Inc.
Orthopedic · 90d
Cleared Jan 16, 1992
CODMAN SOF'WIRE (TM) KIT
K915581 · JDQ
Codman & Shurtleff, Inc.
Orthopedic · 34d
Cleared Jan 16, 1992
CANNULATED DRILL BIT
K915692 · HTW
W.L. Gore & Associates, Inc.
Orthopedic · 24d
Cleared Jan 13, 1992
OREGON FIXATION SCREW
K910976 · HWC
Acu Med, Inc.
Orthopedic · 312d
Cleared Jan 13, 1992
INTERLOCKING FEMORAL NAILING SYSTEM
K912930 · HSB
Stryker Corp.
Orthopedic · 192d
Cleared Jan 13, 1992
TI-FIT FEMORAL COMPONENT
K914343 · LWJ
Smith & Nephew Richards, Inc.
Orthopedic · 108d
Cleared Jan 13, 1992
EXACTECH CERAMIC FEMORAL HEAD COMPONENT
K914574 · LZO
Exactech, Inc.
Orthopedic · 90d
Cleared Jan 13, 1992
ZIMMER(R) CERAMIC FEMORAL HEADS 28MM DIAMETER
K914676 · LZO
Zimmer, Inc.
Orthopedic · 87d
Cleared Jan 13, 1992
M170 PNEUMATICALLY OPERATED OSCILLATING SAW
K914845 · HSZ
Desutter Medical , Ltd.
Orthopedic · 77d
Cleared Jan 09, 1992
K-CAP-E, STERILE
K914812 · LYT
Westcon Orthopedics, Inc.
Orthopedic · 76d
Cleared Jan 02, 1992
PMI (PATIENT MATCHED IMPLANTS) HIP FEMORAL COMP
K911802 · JDI
Biomet, Inc.
Orthopedic · 254d
Cleared Dec 30, 1991
S-ROM ZT HA PROXIMAL FEMORAL SLEEVE
K912713 · MEH
Joint Medical Products Corp.
Orthopedic · 193d
Cleared Dec 30, 1991
OSTEO CERCLAGE WIRE
K914374 · JDQ
Osteo AG
Orthopedic · 90d
Cleared Dec 27, 1991
GENESIS UNICOMPARTMENTAL KNEE SYSTEM
K912735 · HSX
Smith & Nephew Richards, Inc.
Orthopedic · 190d
Cleared Dec 27, 1991
KIRSCHNER(R) HYBRIDFIT TOTAL KNEE SYSTEM
K913492 · JWH
Kirschner Medical Corp.
Orthopedic · 143d
Cleared Dec 24, 1991
LIMA 28MM CERAMIC HEAD, MODIFICATION
K912985 · LZO
Turnkey Intergration USA, Inc.
Orthopedic · 175d