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
16513–16536 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 07, 1989
TRANS-ORAL DEPTH GAUGE
K893415 · LYQ
Ruggles Corp.
Orthopedic · 36d
Cleared Jun 06, 1989
KDG ACETABULAR COMPONENT
K891262 · LWJ
Osteonics Corp.
Orthopedic · 90d
Cleared Jun 05, 1989
ALTA HOLLOW TIBIAL RODS
K890936 · HSB
Howmedica Corp.
Orthopedic · 101d
Cleared Jun 02, 1989
KIRSCHNER SPINAL FIXATOR KMS-1
K884690 · KWP
Kirschner Medical Corp.
Orthopedic · 205d
Cleared May 26, 1989
RESUBMITTED CLW ACETABULAR CUP W/SULMESH
K883794 · LWJ
Protek, Inc.
Orthopedic · 261d
Cleared May 23, 1989
BIPOLAR HIP SYSTEM
K892398 · KXA
Orthomet, Inc.
Orthopedic · 46d
Cleared May 22, 1989
DUPONT DISTAL HUMERAL NAIL
K890939 · HRS
Howmedica Corp.
Orthopedic · 87d
Cleared May 19, 1989
PERSONAL ALERT ASSIST DEVICE
K890445 · LXI
Silent Call Corp.
Orthopedic · 112d
Cleared May 18, 1989
SGARLATO LESSER TOE IMPLANT
K884739 · KWH
Sgarlato Laboratories, Inc.
Orthopedic · 185d
Cleared May 16, 1989
AML(R) COLLARLESS LATERALIZED FEMORAL HIP
K891482 · KWL
Depuy, Inc.
Orthopedic · 60d
Cleared May 15, 1989
ORTHOPAEDIC STAPLES
K890962 · JDR
Ortho Spectrum, Inc.
Orthopedic · 77d
Cleared May 15, 1989
COHN TARGETEER
K891903 · LXH
Orthopedic Systems, Inc.
Orthopedic · 49d
Cleared May 10, 1989
VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMIC
K884952 · LZO
Protek, Inc.
Orthopedic · 162d
Cleared May 10, 1989
INTRAFORM TOTAL HIP SYSTEM
K890742 · JDI
Orthomet, Inc.
Orthopedic · 86d
Cleared May 03, 1989
ACROMED ILIAC SCREW
K884161 · KWP
Buckman Co., Inc.
Orthopedic · 211d
Cleared May 02, 1989
IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR
K891472 · LZV
Implant Technology, Inc.
Orthopedic · 48d
Cleared Apr 27, 1989
INTERMEDICS SELECT SHOULDER METAL-BACKED GLENOID
K884943 · KWS
Intermedics Orthopedics
Orthopedic · 153d
Cleared Apr 26, 1989
ACROMED SPINAL ROD AND SPINAL HOOKS
K884163 · KWP
Buckman Co., Inc.
Orthopedic · 204d
Cleared Apr 24, 1989
CL UNIVERSAL HIP DEVICE
K885146 · KWI
Lima Intl. Corp.
Orthopedic · 130d
Cleared Apr 19, 1989
UNI-KNEE COMPONENT OF THE NATURAL-KNEE SYSTEM
K883969 · HRY
Intermedics Orthopedics
Orthopedic · 211d
Cleared Apr 19, 1989
POROUS COATED GENESIS FEMORAL COMPONENT
K885036 · JWH
Richards Medical Co., Inc.
Orthopedic · 135d
Cleared Apr 19, 1989
PROSTHETIC CEMENT REMOVER
K890285 · LZV
Albert K. Chin
Orthopedic · 90d
Cleared Apr 07, 1989
PERFECTA II/NON-COATED TOTAL HIP SYSTEM
K884027 · JDI
Orthomet, Inc.
Orthopedic · 196d
Cleared Apr 07, 1989
OMNIFIT CONSTRAINED ACETABULAR BEARING INSERT
K890197 · KWZ
Osteonics Corp.
Orthopedic · 80d