FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Orthopedic ×
17,985 results
13801–13824 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 28, 1998
DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE...
K982662 · HWC
DePuy Orthopaedics, Inc.
Orthopedic · 90d
Cleared Oct 27, 1998
SUMMIT ACETABULAR SYSTEM
K983014 · LPH
Johnson & Johnson Professionals, Inc.
Orthopedic · 60d
Cleared Oct 27, 1998
OSTEO DYNATROC PROXIMAL FEMORAL NAIL
K983339 · HSB
Osteonics Corp.
Orthopedic · 34d
Cleared Oct 26, 1998
SURGICAL DYNAMICS RODDING SYSTEM (PREVIOUSLY KNOWN AS THE AURORA TITANIUM...
K983197 · KWP
United States Surgical, A Division of...
Orthopedic · 45d
Cleared Oct 26, 1998
DEPUY ACE COMPOSITE LOCKING NUT
K983265 · HTN
Depuy Ace Medical Co.
Orthopedic · 39d
Cleared Oct 22, 1998
OLYMPUS ENDOSCOPIC SYSTEM LUMBAR HERNIA DISCECTOMY AND ITS ANCILLARY EQUIPMENT
K982133 · HRX
The Olympus Optical Co.
Orthopedic · 127d
Cleared Oct 21, 1998
ISOLA SPINAL SYSTEM
K980485 · MNI
Acromed Corp.
Orthopedic · 254d
Cleared Oct 21, 1998
ZETA MULTIZONE SCN LOCKING NAIL
K982873 · HSB
Howmedica Corp.
Orthopedic · 68d
Cleared Oct 21, 1998
SULZER ORTHOPEDICS FLUTED STEMS
K982903 · JWH
Sulzer Orthopedics, Inc.
Orthopedic · 64d
Cleared Oct 21, 1998
THREADED FIXATION PIN
K982931 · JDW
Sgarlato Laboratories, Inc.
Orthopedic · 62d
Cleared Oct 21, 1998
OSTEONICS EXTENDED FEMORAL BEARING HEAD
K982936 · LWJ
Osteonics Corp.
Orthopedic · 61d
Cleared Oct 21, 1998
TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES
K982953 · HSB
Biomet, Inc.
Orthopedic · 58d
Cleared Oct 21, 1998
SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM
K982987 · MNI
Synthes Spine
Orthopedic · 56d
Cleared Oct 21, 1998
TSRH SPINAL SYSTEM
K982990 · MNI
Sofamor Danek USA,Inc.
Orthopedic · 56d
Cleared Oct 21, 1998
BIO-ANCHOR, PRE-LOADED BIOABSORBABLE SUTURE ANCHOR
K983186 · MAI
Linvatec Corp.
Orthopedic · 40d
Cleared Oct 21, 1998
MODIFICATION TO SPINAL CONCEPTS BACFIX SPINAL FIXATION SYSTEM
K983258 · MNI
Spinal Concepts, Inc.
Orthopedic · 35d
Cleared Oct 21, 1998
MODIFICATION TO SPINAL CONCEPTS BACFIX TI SPINAL FIXATION SYSTEM
K983260 · MNI
Spinal Concepts, Inc.
Orthopedic · 35d
Cleared Oct 19, 1998
BMP CABLE SYSTEM
K982545 · JDQ
Biomet, Inc.
Orthopedic · 90d
Cleared Oct 16, 1998
ARTHROTEK INTERFERENCE SCREW
K982497 · HWC
Biomet, Inc.
Orthopedic · 88d
Cleared Oct 16, 1998
HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM
K982531 · HRS
Howmedica Corp.
Orthopedic · 88d
Cleared Oct 13, 1998
MINI-FIXATOR FOR COLLES FRACTURES
K982982 · HRS
Biomet, Inc.
Orthopedic · 48d
Cleared Oct 13, 1998
INNOVASIVE TIBIAL FASTENER
K983056 · MBI
Innovasive Devices, Inc.
Orthopedic · 42d
Cleared Oct 08, 1998
EBI VUECATH ENDOSCOPIC SPINAL SYSTEM
K982484 · HRX
Electro-Biology, Inc.
Orthopedic · 83d
Cleared Oct 08, 1998
SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS)
K982732 · HRS
Synthes
Orthopedic · 64d