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
11017–11040 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 28, 2005
RX90 LOW PROFILE ACETABULAR SYSTEM
K042989 · LPH
Biomet, Inc.
Orthopedic · 181d
Cleared Apr 27, 2005
SYNTHES (USA) 3.5MM CONICAL SCREWS
K050683 · HWC
Synthes (Usa)
Orthopedic · 41d
Cleared Apr 26, 2005
SBI HAND FIXATION SYSTEM (TM)
K050462 · HRS
Small Bone Innovations, LLC
Orthopedic · 62d
Cleared Apr 26, 2005
SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES
K050646 · HRS
Synthes (Usa)
Orthopedic · 43d
Cleared Apr 26, 2005
DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM
K050932 · LXT
Hand Innovations, Inc.
Orthopedic · 12d
Cleared Apr 21, 2005
CAMCERAM TCP
K050357 · MQV
Cam Implants B.V.
Orthopedic · 66d
Cleared Apr 21, 2005
VERTEVIEW ANTERIOR CERVICAL PLATE SYSTEM
K050588 · KWQ
Innovative Spinal Design, LLC
Orthopedic · 44d
Cleared Apr 21, 2005
SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS
K050636 · HWC
Synthes (Usa)
Orthopedic · 41d
Cleared Apr 20, 2005
SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS
K050580 · HRX
Smith & Nephew Endoscopy, Inc.
Orthopedic · 44d
Cleared Apr 20, 2005
MG II TOTAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE COMPONENTS
K050723 · JWH
Zimmer, Inc.
Orthopedic · 30d
Cleared Apr 18, 2005
ADVANCE HA COATED SPIKED TIBIAL BASE AND ADVANCE HA COATED MODULAR KEEL
K043083 · MBH
Wrightmedicaltechnologyinc
Orthopedic · 161d
Cleared Apr 18, 2005
REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L
K043339 · HTY
Xtremi-T, LLC
Orthopedic · 136d
Cleared Apr 18, 2005
WAGNER SL REVISION STEM LATERAL
K043356 · LZO
Zimmer Austin, Inc.
Orthopedic · 133d
Cleared Apr 18, 2005
NOVEL VBR SPINAL SYSTEM
K050553 · MQP
Alphatec/Nexmed
Orthopedic · 46d
Cleared Apr 15, 2005
THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10
K050101 · HRS
Zimmer Trabecular
Orthopedic · 87d
Cleared Apr 15, 2005
ARTHERX CORKSCREW FT II SUTURE ANCHOR
K050358 · HWC
Arthrex, Inc.
Orthopedic · 60d
Cleared Apr 15, 2005
MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004
K050699 · JDK
Amedica Corp.
Orthopedic · 28d
Cleared Apr 11, 2005
ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM LINER
K042565 · LPH
Ortho Development Corp.
Orthopedic · 202d
Cleared Apr 11, 2005
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K043053 · KWP
Medtronic Sofamor Danek
Orthopedic · 157d
Cleared Apr 11, 2005
OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER
K050490 · MQV
Medicrea
Orthopedic · 45d
Cleared Apr 11, 2005
SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO)
K050607 · HRS
Synthes (Usa)
Orthopedic · 32d
Cleared Apr 11, 2005
STRYKER SPINE AVS PL PEEK SPACER
K050624 · MQP
Stryker Spine
Orthopedic · 31d
Cleared Apr 11, 2005
SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSION
K050631 · LXT
Synthes (Usa)
Orthopedic · 31d
Cleared Apr 11, 2005
GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G,...
K050666 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 28d