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
6817–6840 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 24, 2013
LOTUS
K131427 · KWP
Spinal Elements, Inc.
Orthopedic · 160d
Cleared Oct 24, 2013
BIOPRO - INFINITY PLATE ANCHOR SYSTEM
K132510 · HTN
Biopro, Inc.
Orthopedic · 73d
Cleared Oct 23, 2013
CALIX LUMBAR SPINAL IMPLANT SYSTEM
K131350 · MAX
X-Spine Systems, Inc.
Orthopedic · 166d
Cleared Oct 23, 2013
EVOLUTION MP ADAPTIVE PS TIBIAL INSERT
K131679 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 135d
Cleared Oct 23, 2013
VARIAX 2 SYSTEM
K132502 · HRS
Stryker Trauma AG
Orthopedic · 75d
Cleared Oct 23, 2013
WMT IMPLANTABLE K-WIRE
K132895 · HTY
Wrightmedicaltechnologyinc
Orthopedic · 37d
Cleared Oct 22, 2013
LESSER METATARSAL HEAD IMPLANT SYSTEM
K131187 · KWD
Solana Surgical, LLC
Orthopedic · 179d
Cleared Oct 22, 2013
SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS
K132435 · LZO
Smith & Nephew, Inc.
Orthopedic · 78d
Cleared Oct 18, 2013
NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS
K122437 · MBI
Biomet Sports Medicine
Orthopedic · 434d
Cleared Oct 17, 2013
TRUE SPINAL FIXATION SYSTEM
K130958 · MNI
Innovative Surgical Designs
Orthopedic · 195d
Cleared Oct 17, 2013
UNIVATION
K131167 · HRY
Aesculap Implant Systems, LLC
Orthopedic · 176d
Cleared Oct 17, 2013
AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE
K131459 · JDW
Aap Implantate AG
Orthopedic · 150d
Cleared Oct 16, 2013
PROW FUSION
K130254 · MAX
Nlt Spine, Ltd.
Orthopedic · 257d
Cleared Oct 16, 2013
OVATION 10/12 HIP STEM
K131022 · LPH
Ortho Development Corp.
Orthopedic · 187d
Cleared Oct 16, 2013
AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS,...
K131231 · PHX
Tornier S.A.S.
Orthopedic · 169d
Cleared Oct 16, 2013
IFUSE IMPLANT SYSTEM
K131405 · OUR
SI-BONE, Inc.
Orthopedic · 154d
Cleared Oct 16, 2013
SMOOTH OR THREADED METALLIC BONE FASTENER
K131640 · HTY
Biomedical Ent., Inc.
Orthopedic · 134d
Cleared Oct 16, 2013
A.I.M. SUTURE ANCHOR
K132461 · MBI
Anchor Innovation Medical, Inc.
Orthopedic · 70d
Cleared Oct 11, 2013
BALANCED KNEE SYSTEM HIGH FLEX VITAMIN E PS TIBIAL INSERT AND PATELLA
K131337 · JWH
Ortho Development Corp.
Orthopedic · 155d
Cleared Oct 11, 2013
PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
K131677 · HSB
Ellipse Technologies, Inc.
Orthopedic · 123d
Cleared Oct 11, 2013
OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM...
K132161 · JWH
Exactech, Inc.
Orthopedic · 91d
Cleared Oct 10, 2013
POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA
K130728 · LZO
Smith & Nephew, Inc.
Orthopedic · 206d
Cleared Oct 10, 2013
IDYS LIF CAGES
K131178 · MAX
Clariance
Orthopedic · 168d
Cleared Oct 10, 2013
T2 TIBIAL NAILING SYSTEM
K131365 · HSB
Stryker Trauma AG
Orthopedic · 150d