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
13465–13488 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 24, 1999
DALL-MILES CABLE GRIP (A-GRIP)
K984432 · JDQ
Howmedica Osteonics Corp.
Orthopedic · 72d
Cleared Feb 24, 1999
OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE
K984585 · KWL
Osteonics Corp.
Orthopedic · 62d
Cleared Feb 24, 1999
J-SERIES OMEGA TOTAL HIP SYSTEM
K990003 · LPH
Osteoimplant Technology, Inc.
Orthopedic · 51d
Cleared Feb 18, 1999
LATERALIZED INTERGRAL POROUS PRIMARY FEMORAL COMPONENT
K984296 · LPH
Biomet, Inc.
Orthopedic · 79d
Cleared Feb 18, 1999
SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM
K984498 · KTT
Synthes (Usa)
Orthopedic · 63d
Cleared Feb 18, 1999
MODULAR PROTUSIO CUP
K990032 · JDI
Biomet, Inc.
Orthopedic · 43d
Cleared Feb 18, 1999
KMI WRIST FUSION SYSTEM
K990094 · HRS
Kinetikos Medical, Inc.
Orthopedic · 37d
Cleared Feb 18, 1999
ANATOMICA HUMERAL STEM/HEAD COMPONENTS
K990137 · KWS
Sulzer Orthopedics, Inc.
Orthopedic · 35d
Cleared Feb 18, 1999
OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS
K990203 · MEH
Osteonics Corp.
Orthopedic · 28d
Cleared Feb 16, 1999
MICROTAC-BONE ANCHOR SYSTEM
K990160 · MBI
Influence, Inc.
Orthopedic · 28d
Cleared Feb 12, 1999
130 MODIFIED INTEGRAL FEMORAL COMPONENT
K984408 · LPH
Biomet, Inc.
Orthopedic · 65d
Cleared Feb 12, 1999
AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147
K984442 · JEC
Hand Biomechanics Lab, Inc.
Orthopedic · 60d
Cleared Feb 12, 1999
SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM
K990005 · KWQ
Spinal Concepts, Inc.
Orthopedic · 39d
Cleared Feb 11, 1999
APF POROUS COATED LINE EXTENSION
K984154 · JDI
Biomet, Inc.
Orthopedic · 84d
Cleared Feb 05, 1999
HOWMEDICA HUMERAL INTERCALARY SYSTEM
K984202 · HSD
Howmedica, Inc.
Orthopedic · 73d
Cleared Feb 04, 1999
MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM
K990197 · MEH
Exactech, Inc.
Orthopedic · 15d
Cleared Feb 03, 1999
INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT
K983509 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 119d
Cleared Feb 03, 1999
STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL...
K984209 · HWC
Biomet, Inc.
Orthopedic · 71d
Cleared Feb 03, 1999
ADVANCED REVISION PRODUCT LINE EXTENSION
K990030 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 29d
Cleared Feb 01, 1999
IMPLEX SCREW AND WASHER SYSTEM
K982751 · MBI
Implex Corp.
Orthopedic · 179d
Cleared Feb 01, 1999
CONTINUUM KNEE SYSTEM COBALT CHROMIUM ALLOY TIBIAL COMPONENT
K984291 · JWH
Implex Corp.
Orthopedic · 62d
Cleared Feb 01, 1999
ZETA MULTIZONE LOCKING NAIL SYSTEM
K984305 · HSB
Howmedica, Inc.
Orthopedic · 61d
Cleared Feb 01, 1999
STRAIGHT-IN-ORTHOPEDIC BONE SCREW FIXATION SYSTEM
K990095 · MBI
Influence, Inc.
Orthopedic · 20d
Cleared Feb 01, 1999
MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE
K990120 · HSB
Depuy Ace Medical Co.
Orthopedic · 19d