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
11281–11304 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 14, 2004
OPUS MINIMAGNUM ANCHOR WITH INSERTER
K042584 · HWC
Opus Medical, Inc.
Orthopedic · 83d
Cleared Dec 14, 2004
BIOPLUS
K042636 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 78d
Cleared Dec 14, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K042962 · NKB
Medtronic Sofamor Danek
Orthopedic · 48d
Cleared Dec 14, 2004
ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR
K043337 · HWC
Arthrex, Inc.
Orthopedic · 11d
Cleared Dec 13, 2004
EBI ARRAY SPINAL FIXATION SYSTEM AND SPINELINK II SPINAL FIXATION DEVICE
K042772 · NKB
Ebi, L.P.
Orthopedic · 69d
Cleared Dec 10, 2004
PERIARTICULAR LOCKING PLATES, 2358 SERIES
K043227 · HRS
Zimmer, Inc.
Orthopedic · 18d
Cleared Dec 08, 2004
LPS UPPER EXTREMITY
K042664 · JDC
Depuy, Inc.
Orthopedic · 71d
Cleared Dec 08, 2004
BICONTACT HIP SYSTEM WITH U-CAP
K043079 · MEH
Aesculap
Orthopedic · 30d
Cleared Dec 07, 2004
AEQUOS
K033260 · JWH
Aap Implantate AG
Orthopedic · 425d
Cleared Dec 06, 2004
NEXFLEX TOTAL HIP SYSTEM
K042252 · LPH
Alphatec/Nexmed
Orthopedic · 108d
Cleared Dec 02, 2004
MODULAR ARTHRODESIS NAIL
K042409 · HSB
Biomet, Inc.
Orthopedic · 90d
Cleared Dec 01, 2004
MX POLYAXIAL PEDICLE SCREW
K043001 · MNH
Scient'X
Orthopedic · 30d
Cleared Nov 24, 2004
KASIOS TCP
K042340 · MQV
Kasios Biomaterials
Orthopedic · 86d
Cleared Nov 24, 2004
KOBRA GPS FIXATION SYSTEM
K042859 · KWQ
Medtronic Vertelink, Inc.
Orthopedic · 40d
Cleared Nov 24, 2004
TRIGEN HINDFOOT FUSION NAIL
K043052 · HSB
Smith & Nephew, Inc.
Orthopedic · 19d
Cleared Nov 23, 2004
UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
K042544 · KWQ
Depuy Spine, Inc.
Orthopedic · 64d
Cleared Nov 23, 2004
UNI-THREAD SPINAL SYSTEM
K042640 · MNH
Spine Vision, Inc.
Orthopedic · 57d
Cleared Nov 23, 2004
SILHOUETTE SPINAL FIXATION SYSTEM
K042702 · NKB
Zimmer Spine, Inc.
Orthopedic · 54d
Cleared Nov 23, 2004
SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT
K042883 · JWH
Howmedica Osteonics Corp.
Orthopedic · 35d
Cleared Nov 23, 2004
THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER...
K043061 · KWS
Zimmer Trabecular
Orthopedic · 18d
Cleared Nov 23, 2004
THE TOSCA ANTERIOR CERVICAL PLATE SYSTEM
K043082 · KWQ
Signus Medizintechnik GmbH
Orthopedic · 15d
Cleared Nov 22, 2004
PERFECTA FEMORAL STEM
K031402 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 567d
Cleared Nov 22, 2004
MODIFICATION TO PROTEX STABILIZATION SYSTEM
K042953 · NKB
Globus Medical, Inc.
Orthopedic · 27d
Cleared Nov 22, 2004
MX MONOAXIAL PEDICLE SCREW
K042964 · MNH
Scient'X
Orthopedic · 26d