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
16057–16080 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 28, 1991
ANATOMIC TOE SYSTEM
K911552 · LZJ
Orthopaedic Biosystems
Orthopedic · 81d
Cleared Jun 28, 1991
TEMPERLITE(TM) SAW BLADE
K911902 · HSD
Sierra Surgical, Inc.
Orthopedic · 63d
Cleared Jun 27, 1991
KEANE UNI KNEE SYSTEM
K910807 · HSX
Depuy, Inc.
Orthopedic · 121d
Cleared Jun 27, 1991
ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM
K911398 · HWC
Howmedica Corp.
Orthopedic · 90d
Cleared Jun 27, 1991
BIOMET COBALT-CHROME FEMORAL COMPONENTS
K911684 · JDI
Biomet, Inc.
Orthopedic · 72d
Cleared Jun 26, 1991
OSTEONICS ION IMPLANT MOD-ML UNIKNEE FEMORAL COMP
K911373 · HRY
Osteonics Corp.
Orthopedic · 90d
Cleared Jun 24, 1991
TMP MANDIBULAR COMPRESSION SYSTEM
K905024 · HRS
Techmedica, Inc.
Orthopedic · 229d
Cleared Jun 24, 1991
MTS KNEE SYSTEM
K905613 · JWH
T & R Mfg., Inc.
Orthopedic · 192d
Cleared Jun 21, 1991
FIXATION DEVICES AND BONE PLATE
K910175 · HRS
Micro Surgical Instruments Corp.
Orthopedic · 157d
Cleared Jun 21, 1991
PCA MTK II TOTAL KNEE SYSTEM
K910235 · JWH
Howmedica Corp.
Orthopedic · 154d
Cleared Jun 21, 1991
ISOLA(TM) SPINE SYSTEM--EYE ROD
K911394 · KWP
Acromed Corp.
Orthopedic · 84d
Cleared Jun 19, 1991
OSTEONICS 7000 SERIES TOTAL KNEE TIBIAL COMPONENTS
K910990 · JWH
Osteonics Corp.
Orthopedic · 104d
Cleared Jun 18, 1991
LEVTECH TITANIUM BONE WIRE
K910128 · JDQ
Levtech, Inc.
Orthopedic · 160d
Cleared Jun 17, 1991
TITAN TOTAL HIP DEVICE
K905298 · JDI
Dr. Jean-Marc Guichet
Orthopedic · 202d
Cleared Jun 17, 1991
NEXUS(TM) FEMORAL HIP STEM
K911052 · JDI
Dow Corning Wright
Orthopedic · 101d
Cleared Jun 17, 1991
ARTHROSCOPY INSTRUMENT CANNULA
K911205 · HRX
Davol, Inc.
Orthopedic · 90d
Cleared Jun 14, 1991
LIMA COLLARED CL STEM
K910836 · JDI
Lima Intl. Corp.
Orthopedic · 107d
Cleared Jun 13, 1991
THACKRAY TITANIUM MINI-PLATING SYSTEM
K905774 · HRS
Depuy, Inc.
Orthopedic · 168d
Cleared Jun 13, 1991
BIOPRO METAL BACKED CEMENTED ACETABULAR CUP
K910352 · JDI
Biopro, Inc.
Orthopedic · 135d
Cleared Jun 12, 1991
NOILES(TM) TOTAL KNEE PROSTHESIS, MODIFICATION
K905810 · JWH
Joint Medical Products Corp.
Orthopedic · 168d
Cleared Jun 07, 1991
HYDROXYAPATITE COATED PROFILE(R) HIP STEM
K910156 · MEH
Depuy, Inc.
Orthopedic · 144d
Cleared Jun 05, 1991
OSTEONICS ION IMPLANTED TOTAL KNEE FEMORAL COMP
K910989 · JWH
Osteonics Corp.
Orthopedic · 90d
Cleared May 29, 1991
SGARLATO FLEXIBLE HINGE TOE IMPLANT
K905795 · KWH
Sgarlato Laboratories, Inc.
Orthopedic · 153d
Cleared May 29, 1991
DCW MODULAR DISTAL FEMORAL SYSTEM
K910596 · KRO
Dow Corning Wright
Orthopedic · 106d