FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,766 results
7345–7368 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 09, 2012
MICRO/MINI N-PK(H) BONE ANCHOR
K121356 · MBI
Anulex Technologies, Inc.
Orthopedic · 189d
Cleared Nov 09, 2012
PERSONA NATURAL TIBIA BASEPLATES
K122765 · JWH
Zimmer, Inc.
Orthopedic · 60d
Cleared Nov 08, 2012
AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 SYSTEM
K113601 · HRS
Aap Implantate AG
Orthopedic · 339d
Cleared Nov 08, 2012
MTF FASCIA
K120479 · OWY
Musculoskeletal Transplant Foundation
Orthopedic · 266d
Cleared Nov 07, 2012
Z-SNAP OFF SCREW, Z-DOUBLE THREAD COMPRESSION SCREW, Z-GUIDE WIRE, Z-STAPLE
K121277 · HWC
Z-Medical GmbH & Co. KG
Orthopedic · 194d
Cleared Nov 07, 2012
PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM
K121725 · KWP
Pioneer Surgical Technology, Inc.
Orthopedic · 148d
Cleared Nov 07, 2012
ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM
K121771 · MBH
Zimmer, Inc.
Orthopedic · 145d
Cleared Nov 07, 2012
GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET
K122738 · HWC
Solana Surgical, LLC
Orthopedic · 62d
Cleared Nov 07, 2012
HAMMER TOE IMPLANT
K122959 · HWC
Trilliant Surgical, Ltd.
Orthopedic · 43d
Cleared Nov 06, 2012
INSURGICAL SINGLE USE POWER EQUIPMENT
K112599 · KIJ
Insurgical, LLC
Orthopedic · 426d
Cleared Nov 05, 2012
TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT
K121509 · KWY
Tgm Medical, Inc.
Orthopedic · 168d
Cleared Nov 05, 2012
DYMAXEON SPINE SYSTEM
K121786 · NKB
B2b Spine Pty, Ltd.
Orthopedic · 140d
Cleared Nov 05, 2012
CS2 HIP SYSTEM
K122512 · LPH
Consensus Orthopedics, Inc.
Orthopedic · 80d
Cleared Nov 02, 2012
REVELATION POROUS COATED HIP STEM, SIZE 8
K122636 · LPH
Encore Medical, L.P.
Orthopedic · 65d
Cleared Nov 01, 2012
FRONTIER SADL INTERBODY FUSION DEVICE
K112700 · OVD
Frontier Medical Devices, Inc.
Orthopedic · 412d
Cleared Oct 31, 2012
AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM
K113602 · HRS
Aap Implantate AG
Orthopedic · 331d
Cleared Oct 31, 2012
CANOPY LAMINOPLASTY FIXATION SYSTEM
K121732 · NQW
Globus Medical, Inc.
Orthopedic · 140d
Cleared Oct 31, 2012
REX ANTERIOR CERVICAL PLATE SYSTEM
K121862 · KWQ
Dio Medical Co., Ltd.
Orthopedic · 127d
Cleared Oct 31, 2012
CERTEX SPINAL IMPLANT SYSTEM
K122163 · MNI
X-Spine Systems, Inc.
Orthopedic · 103d
Cleared Oct 31, 2012
QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY
K122314 · MBI
Cayenne Medical, Inc.
Orthopedic · 91d
Cleared Oct 31, 2012
DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS
K122395 · HSN
DePuy Orthopaedics, Inc.
Orthopedic · 85d
Cleared Oct 30, 2012
BIOPRO HEMI-EDGE TOE SYSTEM
K121973 · KWD
Biopro, Inc.
Orthopedic · 117d
Cleared Oct 26, 2012
COLUMBUS REVISION KNEE SYSTEM
K122985 · JWH
Aesculap Implant System, Inc.
Orthopedic · 30d
Cleared Oct 25, 2012
ANCHOR-L LUMBAR CAGE
K120869 · OVD
Stryker Spine
Orthopedic · 217d