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
8713–8736 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 30, 2010
GRYPHON T BR DS ANCHOR W/ORTHOCORD, GRYPHON T BR ANCHOR W /ORTHOCORD, GRYPHON...
K100012 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 116d
Cleared Apr 30, 2010
AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 5MM LOCKING INSERTS
K100475 · HRS
Howmedica Osteonics Corp.
Orthopedic · 71d
Cleared Apr 28, 2010
EPICAGE INTERBODY FUSION DEVICE
K092901 · MAX
R Tree Innovations
Orthopedic · 219d
Cleared Apr 28, 2010
ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM
K093561 · LPH
Zimmer, Inc.
Orthopedic · 161d
Cleared Apr 28, 2010
EXTREMITY MEDICAL SCREW SYSTEM
K093770 · HWC
Extremity Medical, LLC
Orthopedic · 141d
Cleared Apr 28, 2010
PIEZOELECTRIC SYSTEM
K100410 · JDX
Satelec
Orthopedic · 71d
Cleared Apr 28, 2010
PROFEMUR HIP SYSTEM MODULAR NECKS
K100866 · LZO
Wrightmedicaltechnologyinc
Orthopedic · 30d
Cleared Apr 26, 2010
SURESHOT TAN NAILS AND ACCESSORIES
K092748 · HSB
Smith & Nephew, Inc.
Orthopedic · 230d
Cleared Apr 26, 2010
ENDURAMESH, MODEL 762.XXX
K093207 · MQP
Lucero Medical, LLC
Orthopedic · 195d
Cleared Apr 26, 2010
CRESCENT SPINAL SYSTEM
K094025 · MAX
Medtronic Sofamor Danek
Orthopedic · 117d
Cleared Apr 22, 2010
GRAFTY QUICKSET
K093343 · MQV
Graftys
Orthopedic · 178d
Cleared Apr 22, 2010
MODIFICAITON TO: CARDO MEDICAL HIP SYSTEM
K094045 · LPH
Cardo Medical Corp.
Orthopedic · 112d
Cleared Apr 22, 2010
NANOSS BONE VOID FILLER
K100361 · MQV
Pioneer Surgical Technology
Orthopedic · 69d
Cleared Apr 22, 2010
DIAMONDBACK SPINAL SYSTEM
K100377 · MNI
Eminent Spine
Orthopedic · 69d
Cleared Apr 21, 2010
SMITH & NEPHEW HIP SYSTEMS WITH HA
K090982 · MEH
Smith & Nephew, Inc.
Orthopedic · 379d
Cleared Apr 20, 2010
DISTALOCK FEMORAL INTRAMEDULLARY NAIL SYSTEM
K100312 · HSB
Dgimed Ortho, Inc.
Orthopedic · 75d
Cleared Apr 20, 2010
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY
K100618 · HRS
Orthohelix Surgical Designs, Inc.
Orthopedic · 47d
Cleared Apr 19, 2010
SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR
K100159 · MBI
Smith & Nephew Inc., Endoscopy Div.
Orthopedic · 89d
Cleared Apr 16, 2010
PEANUT GROWTH CONTROL PLATING SYSTEM
K093880 · HRS
Ebi, L.P.
Orthopedic · 119d
Cleared Apr 15, 2010
CORMET CEMENTLESS RESURFACING FEMORAL HEAD
K092198 · KXA
Corin USA
Orthopedic · 268d
Cleared Apr 15, 2010
SLR-PLUS STANDARD AND LATERAL FEMORAL STEMS
K093991 · LZO
Smith & Nephew, Inc.
Orthopedic · 112d
Cleared Apr 15, 2010
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
K100191 · KWP
Lanx, Inc.
Orthopedic · 83d
Cleared Apr 14, 2010
VERILAST WEAR CLAIMS FOR THE LEGION PRIMARY KNEE SYSTEM
K093746 · JWH
Smith & Nephew, Inc.
Orthopedic · 131d
Cleared Apr 13, 2010
ZUMA-C
K092521 · OVE
Seaspine, Inc.
Orthopedic · 238d