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
12721–12744 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 20, 2001
STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX
K011319 · JDW
Stryker Endoscopy
Orthopedic · 80d
Cleared Jul 20, 2001
COLOR BUFFED (CB) DDH FEMORAL STEM
K012019 · JDI
Biomet, Inc.
Orthopedic · 22d
Cleared Jul 20, 2001
MODIFICATION TO XIA SPINE SYSTEM
K012027 · MNH
Howmedica Osteonics
Orthopedic · 22d
Cleared Jul 19, 2001
PRO OSTEON 200R WITH CALCIUM SULFATE, MODELS 2RCS038, 2RCS050, 2RCS075,...
K004003 · MQV
Interpore Cross Intl.
Orthopedic · 206d
Cleared Jul 19, 2001
NEXGEN PRIMARY POROUS PATELLA, MODEL...
K011904 · JWH
Implex Corp.
Orthopedic · 30d
Cleared Jul 19, 2001
SYNTHES CERVIFIX SYSTEM
K011969 · KWP
Synthes (Usa)
Orthopedic · 24d
Cleared Jul 18, 2001
SURGICAL DYNAMICS MESH CAGE SYSTEM
K003709 · MQP
United States Surgical, A Division of...
Orthopedic · 229d
Cleared Jul 18, 2001
SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
K010681 · KWP
Depuyacromed
Orthopedic · 133d
Cleared Jul 18, 2001
BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER
K011455 · JDI
Biomet, Inc.
Orthopedic · 68d
Cleared Jul 18, 2001
1.5MM BONE FIXATION KIT
K012000 · HWC
Bionx Implants, Ltd.
Orthopedic · 21d
Cleared Jul 18, 2001
SMARTSCREW
K012001 · HWC
Bionx Implants, Ltd.
Orthopedic · 21d
Cleared Jul 18, 2001
TRIDENT ALL POLY CUP
K012026 · JDI
Howmedica Osteonics Corp.
Orthopedic · 20d
Cleared Jul 16, 2001
LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW
K011076 · HRS
Walter Lorenz Surgical, Inc.
Orthopedic · 98d
Cleared Jul 16, 2001
OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION)
K011976 · JWH
Exactech, Inc.
Orthopedic · 21d
Cleared Jul 13, 2001
METAL TRANSCEND ARTICULATION SYSTEM
K004043 · JDL
Wrightmedicaltechnologyinc
Orthopedic · 196d
Cleared Jul 13, 2001
POLY-TAPES WITH THE FASTLOK FIXATION DEVICE
K010051 · JDR
Xiros Plc
Orthopedic · 186d
Cleared Jul 13, 2001
IN-FAST BONE SCREW SYSTEM
K011910 · HWC
American Medical Systems, Inc.
Orthopedic · 24d
Cleared Jul 13, 2001
AEQUALIS PRESS-FIT SHOULDER PROSTHESIS
K011942 · HSD
Tornier
Orthopedic · 22d
Cleared Jul 13, 2001
HOFFMAN II HYBRID RING CLAMP
K011948 · LXT
Howmedica Osteonics Corp.
Orthopedic · 22d
Cleared Jul 12, 2001
STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT
K003954 · MQV
Biocomposites, Ltd.
Orthopedic · 203d
Cleared Jul 11, 2001
SCS DT-02 TRANSVERSE CONNECTOR
K003823 · KWP
Ortho Tec, LLC
Orthopedic · 212d
Cleared Jul 11, 2001
SIGN IM NAIL
K011129 · HSB
Sign, Inc.
Orthopedic · 89d
Cleared Jul 10, 2001
OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT
K011138 · HRY
Biomet, Inc.
Orthopedic · 88d
Cleared Jul 06, 2001
GLOBAL FX POROUS-COATED HUMERAL STEM
K011099 · MBF
DePuy Orthopaedics, Inc.
Orthopedic · 86d