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
12145–12168 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Sep 23, 2002
TOTAL KNEE CEMENTED, SEMI-CONSTRAINED
K021740 · JWH
Dj Orthopedics, LLC
Orthopedic · 118d
Cleared Sep 23, 2002
HIP TOOL IMPLANT
K022139 · HRS
Orthopedic Sciences, Inc.
Orthopedic · 83d
Cleared Sep 23, 2002
PLUS PIVOT LINK UNIVERSAL SYSTEM
K022271 · MNI
Spine Vision, Inc.
Orthopedic · 72d
Cleared Sep 23, 2002
RESTORATION MODULAR SYSTEM
K022549 · LZO
Howmedica Osteonics Corp.
Orthopedic · 53d
Cleared Sep 23, 2002
SIGN IM NAIL
K022632 · HSB
Surgical Implant Generation Network...
Orthopedic · 47d
Cleared Sep 23, 2002
ORTHOGUARD AB ANTIMICROBIAL SLEEVE
K022676 · JEC
Smith & Nephew, Inc.
Orthopedic · 42d
Cleared Sep 23, 2002
TWIN FIX
K022771 · KTT
Fixano SA
Orthopedic · 33d
Cleared Sep 18, 2002
REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS
K022744 · HWE
Medical Device Services
Orthopedic · 30d
Cleared Sep 18, 2002
MODIFICATION TO TSRH SPINAL SYSTEM
K022778 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Sep 17, 2002
PREMIER ANTERIOR CERVICAL PLATE SYSTEM
K021761 · KWQ
Medtronic Sofamor Danek
Orthopedic · 111d
Cleared Sep 17, 2002
NORMED TITANIUM CALCANEUS PLATING WITH LOCKING SCREW SYSTEM
K022324 · HRS
Osteomedics, Inc.
Orthopedic · 62d
Cleared Sep 17, 2002
EXTERNAL FIXATION RING
K022423 · KTT
Rigid FX Orthopedics, Incorporated
Orthopedic · 55d
Cleared Sep 17, 2002
BIOMET CALCANEAL PLATE
K022515 · HRS
Biomet Orthopedics, Inc.
Orthopedic · 49d
Cleared Sep 13, 2002
NORMED DISTAL RADIUS RECONSTRUCTION SYSTEM
K022231 · HRS
Osteomedics, Inc.
Orthopedic · 65d
Cleared Sep 10, 2002
UCR SPINAL SYSTEM, 5.5MM, 8.0MM SCREWS & INSTRUMENTS
K021623 · MNH
Iame, Inc.
Orthopedic · 117d
Cleared Sep 10, 2002
NORMED MINI EXTERNAL FIXATOR SYSTEM
K022230 · HRS
Osteomedics, Inc.
Orthopedic · 62d
Cleared Sep 09, 2002
NORMED TITANIUM RONDO FIX FUSION PLATES AND SCREW SYSTEM
K022323 · HRS
Osteomedics, Inc.
Orthopedic · 54d
Cleared Sep 09, 2002
NORMED TITANIUM OSTEOTOMY PLATING SYSTEM
K022325 · HRS
Osteomedics, Inc.
Orthopedic · 54d
Cleared Sep 06, 2002
CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER
K011531 · MQV
Biomet, Inc.
Orthopedic · 477d
Cleared Sep 06, 2002
ARTHREX UNIVERS FRACTURE PROSTHESIS
K020345 · KWS
Arthrex, Inc.
Orthopedic · 217d
Cleared Sep 06, 2002
SYNTHES 6.5 MM CANNULATED SCREW
K021932 · HWC
Synthes (Usa)
Orthopedic · 86d
Cleared Sep 06, 2002
STAYFUSE GT-IP
K022726 · HWC
Pioneer Surgical Technology
Orthopedic · 21d
Cleared Sep 05, 2002
ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM
K021891 · LPH
Zimmer, Inc.
Orthopedic · 90d
Cleared Sep 05, 2002
HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED, MODEL 7.3MM
K022647 · HWC
Triad Medical, Inc.
Orthopedic · 27d