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
16489–16512 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 03, 1989
GAMMA LOCKING NAIL
K893639 · KTT
Howmedica Corp.
Orthopedic · 83d
Cleared Aug 03, 1989
UNIVERSAL CEMENTED CUP
K894249 · JDI
Orthopedic Systems, Inc.
Orthopedic · 43d
Cleared Aug 01, 1989
INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)
K892376 · HRX
Concept, Inc.
Orthopedic · 118d
Cleared Jul 28, 1989
WHITESIDE ORTHOLOC M.A. TOTAL KNEE SYSTEM
K893252 · JWH
Dow Corning Wright
Orthopedic · 91d
Cleared Jul 28, 1989
GRIPPER II ACETABULAR CUP
K893584 · LWJ
Joint Medical Products Corp.
Orthopedic · 80d
Cleared Jul 25, 1989
SONGER WIRING SYSTEM
K892651 · LRN
Danek Medical, Inc.
Orthopedic · 103d
Cleared Jul 25, 1989
P.S.A. FEMORAL HIP PROSTHESIS
K893959 · KWY
Protek, Inc.
Orthopedic · 54d
Cleared Jul 25, 1989
MEDSCOPE 4MM ARTHROSCOPE
K894303 · HRX
Medscope Corp.
Orthopedic · 32d
Cleared Jul 19, 1989
POROUS GENESIS PATELLAR AND STEMLESS TIBIAL COMP.
K890132 · JWH
Richards Medical Co., Inc.
Orthopedic · 188d
Cleared Jul 19, 1989
FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR
K892059 · LZY
Protek, Inc.
Orthopedic · 112d
Cleared Jul 19, 1989
POROUS GENESIS STEMMED TIBIAL COMPONENT
K892366 · JWH
Richards Medical Co., Inc.
Orthopedic · 104d
Cleared Jul 19, 1989
P.F.C. MODULAR KNEE SYSTEM, TIBIAL TRAY-POROUS
K892394 · JWH
Johnson & Johnson Professionals, Inc.
Orthopedic · 103d
Cleared Jun 23, 1989
PS3500 ARTHROSCOPIC SURGICAL SYSTEM
K892062 · HRX
Dyonics, Inc.
Orthopedic · 85d
Cleared Jun 22, 1989
SELBY INSTRUMENTATION
K884998 · KWP
Advanced Spine Fixation Systems, Inc.
Orthopedic · 202d
Cleared Jun 22, 1989
OMNIFIT CERAMIC MORSE TAPER HEAD (1002 SERIES)
K885102 · LZO
Osteonics Corp.
Orthopedic · 192d
Cleared Jun 22, 1989
APR COLLARED REVISION FEMORAL COMPONENT
K885192 · JDI
Intermedics Orthopedics
Orthopedic · 188d
Cleared Jun 22, 1989
REVERSE CUTTING CANNULATED CANCELLOUS BONE SCREW
K892214 · HWC
Ace Medical Co.
Orthopedic · 80d
Cleared Jun 22, 1989
REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS
K892937 · JDZ
Dentsply Intl.
Orthopedic · 62d
Cleared Jun 13, 1989
DANEK RING FIXATOR (DRF)
K890814 · KTT
Danek Medical, Inc.
Orthopedic · 117d
Cleared Jun 12, 1989
MODIFIED PROFILE HIP ACETABULAR PROSTHESIS
K891408 · JDX
Depuy, Inc.
Orthopedic · 90d
Cleared Jun 09, 1989
CERAMIC TOTAL HIP BALL HEAD, LARGE TAPER
K891082 · LZO
Depuy, Inc.
Orthopedic · 100d
Cleared Jun 09, 1989
CERAMIC TOTAL HIP BALL HEAD, SMALL TAPER
K891083 · LZO
Depuy, Inc.
Orthopedic · 100d
Cleared Jun 08, 1989
CTI II STRAIGHT STEM
K891539 · LWJ
Orthopedic Systems, Inc.
Orthopedic · 83d
Cleared Jun 07, 1989
EXETER II TOTAL HIP SYSTEM
K891454 · JDI
Howmedica Corp.
Orthopedic · 84d