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
11497–11520 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 30, 2004
LACTOSCREW SCREW ANCHOR
K033355 · HWC
Biomet Orthopedics, Inc.
Orthopedic · 254d
Cleared Jun 30, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K041030 · MNI
Medtronic Sofamor Danek
Orthopedic · 70d
Cleared Jun 25, 2004
EBI DISTAL RADIUS PLATING SYSTEM
K040908 · HRS
Ebi, L.P.
Orthopedic · 79d
Cleared Jun 25, 2004
CONSERVE PLUS REVISION SHELL AND CONSERVE PLUS THICK SHELL
K041425 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 28d
Cleared Jun 25, 2004
OPUS MAGNUM ANCHOR WITH INSERTER
K041440 · MBI
Opus Medical, Inc.
Orthopedic · 24d
Cleared Jun 24, 2004
BIO-EUROLIG INTERFERENCE SCREW
K031939 · HWC
Fournitures Hospitalieres Industrie
Orthopedic · 367d
Cleared Jun 24, 2004
WAFER SYSTEM
K033303 · HRS
Spine Wave, Inc.
Orthopedic · 254d
Cleared Jun 24, 2004
TSY SHOULDER PLATE IMPLANT
K040850 · HRS
Orthopedic Sciences, Inc.
Orthopedic · 85d
Cleared Jun 24, 2004
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K041452 · MQP
Medtronic Sofamor Danek
Orthopedic · 23d
Cleared Jun 18, 2004
LCP RADIAL HEAD PLATING SYSTEM
K040777 · HRS
Synthes (Usa)
Orthopedic · 84d
Cleared Jun 17, 2004
SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
K040612 · HRX
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 101d
Cleared Jun 17, 2004
ASSURE ANTERIOR CERVICAL PLATE SYSTEM
K040721 · KWQ
Globus Medical, Inc.
Orthopedic · 90d
Cleared Jun 17, 2004
ALADYN RIGID SPINE PLATE
K040747 · MNH
Scient'X
Orthopedic · 86d
Cleared Jun 17, 2004
MODULAR REPLACEMENT SYSTEM CEMENTED STEMS
K040749 · KRO
Howmedica Osteonics Corp.
Orthopedic · 86d
Cleared Jun 17, 2004
EXACTECH RESORBABLE ROOM TEMPERATURE BONE PASTE
K040755 · MQV
Exactech, Inc.
Orthopedic · 85d
Cleared Jun 17, 2004
INTEGRA BONE FIXATION SYSTEM
K040860 · HRS
Integra LifeSciences Corporation
Orthopedic · 76d
Cleared Jun 17, 2004
AEQUALIS SHOULDER SYSTEM
K041339 · KWS
Tornier
Orthopedic · 28d
Cleared Jun 15, 2004
SYNTHES (USA) HYDROXYAPATITE (HA) COATED SCHANZ SCREWS
K040701 · HWC
Synthes (Usa)
Orthopedic · 90d
Cleared Jun 14, 2004
CONTOUR HA COATED RECONSTRUCTION RING
K040680 · MEH
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Jun 14, 2004
STRYKER BIOZIP SUTURE ANCHOR SYSTEM
K041305 · MAI
Stryker Endoscopy
Orthopedic · 28d
Cleared Jun 14, 2004
MODIFICATION TO STRYKER XCEL ANCHOR SYSTEM
K041307 · MAI
Stryker Endoscopy
Orthopedic · 28d
Cleared Jun 14, 2004
STRYKER WEDGE SUTURE ANCHOR SYSTEM
K041310 · MBI
Stryker Endoscopy
Orthopedic · 28d
Cleared Jun 10, 2004
JAX-TCP
K033552 · MQV
Smith & Nephew, Inc.
Orthopedic · 211d
Cleared Jun 10, 2004
MODIFICATION TO TSRH SPINAL SYSTEM
K041282 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d