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
16657–16680 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 29, 1988
KIRSCHNER (R) UNICONDYLAR-II KNEE SYSTEM
K882241 · HRY
Kirschner Medical Corp.
Orthopedic · 33d
Cleared Jun 22, 1988
HJD CALCAR REPLACEMENT PROSTHESIS
K881769 · JDI
Richards Medical Co., Inc.
Orthopedic · 65d
Cleared Jun 17, 1988
PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE
K881378 · LXI
Pfizer, Inc.
Orthopedic · 77d
Cleared Jun 17, 1988
SPINAL DISTRACTORS, SPANNERS
K882069 · LXH
Karlin Technology, Inc.
Orthopedic · 31d
Cleared Jun 17, 1988
MICRODISCECTOMY CURRETTES
K882077 · LXH
Karlin Technology, Inc.
Orthopedic · 31d
Cleared Jun 10, 1988
ACE SCREW REMOVAL TREPHINE
K882008 · HWE
Buckman Co., Inc.
Orthopedic · 28d
Cleared Jun 03, 1988
LIMA-LTO ECS EXTERNAL CIRCULAR STABILIZER
K881673 · JEC
Lima-Lto, Inc.
Orthopedic · 46d
Cleared Jun 03, 1988
COBB SPINAL ELEVATORS
K882068 · KWP
Karlin Technology, Inc.
Orthopedic · 17d
Cleared Jun 03, 1988
LUMBAR IMPACTION SET AND BONE GRAFT IMPACTORS
K882070 · KWP
Karlin Technology, Inc.
Orthopedic · 17d
Cleared May 27, 1988
ACE ICPM SIDE PORTED NEEDLE
K881858 · LXC
Buckman Co., Inc.
Orthopedic · 24d
Cleared May 25, 1988
STUART CANNULATED CANCELLOUS BONE FIXATION SCREW
K881327 · HWC
Stuart Drug & Surgical Supply, Inc.
Orthopedic · 56d
Cleared May 20, 1988
ANATOMIC ADJUSTABLE AXIAL FIXATOR ASSEMBLY
K874377 · LXT
Harrington Arthritis Research Center
Orthopedic · 207d
Cleared May 06, 1988
LCS FEMORAL HIP PROSTHESIS
K880269 · JDI
Depuy, Inc.
Orthopedic · 106d
Cleared May 04, 1988
ARTUS DISPOSABLE SHEATHS/CUTTERS
K880881 · HSZ
Acufex Microsurgical, Inc.
Orthopedic · 63d
Cleared Apr 29, 1988
RESUBMITTING OF HJD TOTAL HIP SYSTEM
K881117 · JDI
Richards Medical Co., Inc.
Orthopedic · 51d
Cleared Apr 27, 1988
ACROMED WASHERS
K881699 · HTN
Buckman Co., Inc.
Orthopedic · 8d
Cleared Apr 22, 1988
S-ROM SUPERCUP ACETABULAR CUP
K870088 · LWJ
Joint Medical Products Corp.
Orthopedic · 469d
Cleared Apr 15, 1988
ACE PNEUMATIC OSCILLATING SAW
K881250 · HSZ
Buckman Co., Inc.
Orthopedic · 23d
Cleared Apr 14, 1988
HERMAN CANNULA SET
K880203 · HRX
Orthopedic Systems, Inc.
Orthopedic · 90d
Cleared Apr 08, 1988
ELITE MODULAR HIP SYSTEM
K871867 · JDI
Thackray USA
Orthopedic · 331d
Cleared Apr 05, 1988
INTRAFORM TOTAL HIP SYSTEM
K880390 · JDI
Orthomet, Inc.
Orthopedic · 67d
Cleared Mar 25, 1988
RSI GLENOID ARCUATE BONE DRILL W/DISP. FLEXI-BITS
K880074 · HSZ
Romano Surgical Instrumentation, Inc.
Orthopedic · 74d
Cleared Mar 25, 1988
TENDON HARVESTER
K880414 · HRX
Concept, Inc.
Orthopedic · 53d
Cleared Mar 23, 1988
BONE SUTURE FIXATION DEVICE
K880264 · HXY
Orthopedic Systems, Inc.
Orthopedic · 61d