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
13321–13344 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 16, 1999
FIRST STEP UNICOMPARTMENTAL KNEE SYSTEM
K992287 · HSX
Howmedica Osteonics Corp.
Orthopedic · 132d
Cleared Nov 16, 1999
XIA SPINAL SYSTEM C-C ADAPTOR
K992792 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 89d
Cleared Nov 16, 1999
SILHOUETTE SPINAL FIXATION SYSTEM
K993067 · KWP
Sulzer Spine-Tech
Orthopedic · 64d
Cleared Nov 16, 1999
MODIFIED BMP TROCHANTERIC PLATES
K993510 · HRS
Biomet, Inc.
Orthopedic · 29d
Cleared Nov 16, 1999
HOWMEDICA OSTEONICS FEMORAL HEADS
K993601 · LWJ
Howmedica Osteonics Corp.
Orthopedic · 22d
Cleared Nov 16, 1999
MODIFIED LONG LENGTH GAMMA NAIL
K993670 · HSB
Howmedica Osteonics Corp.
Orthopedic · 15d
Cleared Nov 10, 1999
FS 1000 KNEE SYSTEM
K991052 · JWH
Renaissance Instruments, LLC
Orthopedic · 225d
Cleared Nov 10, 1999
THE TAPER-FIT TOTAL HIP SYSTEM
K992234 · JDG
Corin USA
Orthopedic · 131d
Cleared Nov 10, 1999
METRX SYSTEM
K993021 · HRX
Surgical Navigation Technologies, Inc.
Orthopedic · 63d
Cleared Nov 09, 1999
MENISCUS ARROW, MODELS 531110, 531113, 531116
K993453 · MAI
Bionx Implants, Ltd.
Orthopedic · 27d
Cleared Nov 08, 1999
ISOBAR SEMI-RIGID SPINAL SYSTEM
K991326 · MNI
Scien'Tx USA, Inc.
Orthopedic · 203d
Cleared Nov 08, 1999
TITANIUM HARTSHILL SYSTEM
K991662 · KWP
Surgicraft , Ltd.
Orthopedic · 178d
Cleared Nov 08, 1999
ADI 9000/9001 ARTHROSCOPE AND ACCESSORIES
K992621 · HRX
Advanced Diagnostics & Interventions
Orthopedic · 95d
Cleared Nov 08, 1999
ISOBAR SPINAL SYSTEM
K992738 · MNI
Encore Orthopedics, Inc.
Orthopedic · 87d
Cleared Nov 08, 1999
LORENZ SMALL FRAGMENT SYSTEM
K992961 · HRS
Walter Lorenz Surgical, Inc.
Orthopedic · 67d
Cleared Nov 08, 1999
DIGIT WIDGET
K992970 · JDW
Hand Biomechanics Lab, Inc.
Orthopedic · 66d
Cleared Nov 05, 1999
DEPUY TOTAL ELBOW SYSTEM
K992656 · JDC
DePuy Orthopaedics, Inc.
Orthopedic · 88d
Cleared Nov 02, 1999
SYNTHES CERCLAGE POSITIONING PIN
K992891 · JDQ
Synthes (Usa)
Orthopedic · 67d
Cleared Oct 29, 1999
MASS (MICRO-ACCESS SPINE SYSTEM)
K992583 · HRX
Omni-Tract Surgical, Div. Minn....
Orthopedic · 88d
Cleared Oct 27, 1999
SDB CERCLAGE SYSTEM
K992616 · JDQ
Pioneer Surgical Technology
Orthopedic · 84d
Cleared Oct 27, 1999
HEX BUTTON
K992617 · HTN
Pioneer Surgical Technology
Orthopedic · 84d
Cleared Oct 27, 1999
ZMR HIP SYSTEM-REVISION TAPER
K992667 · LPH
Zimmer, Inc.
Orthopedic · 79d
Cleared Oct 27, 1999
NEXT GENERATION RODDING SYSTEM
K992784 · KWQ
United States Surgical, A Division of...
Orthopedic · 69d
Cleared Oct 27, 1999
ROTORBLADE SUTURE ANCHOR
K993373 · MAI
Li Medical Technologies, Inc.
Orthopedic · 20d