FDA.reportPublic FDA data

510(k) K211076

Device
Patient Specific Marking Guides
Applicant
Additive Orthopaedics, LLC
510(k) number
K211076
Product code
PBF
Decision
Substantially Equivalent (SESE)
Decision date
2022-06-28
Date received
2021-04-12
Regulation
888.3030
Classification name
Orthopaedic Surgical Planning And Instrument Guides
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Greg Kowalczyk
Address
44 Riverdale Ave. Monmouth Beach NJ US 07750 07750

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K240415Newclip Patient-matched instrumentation non sterile PSINewclip Technics2024-11-07
K240113CORIOGRAPH Knee Pre-Op PlanSmith & Nephew, Inc.2024-03-18
K240066Fine Osteotomy™Bodycad Laboratories, Inc.2024-02-09
K221615Newclip Patient-matched instrumentation non sterile PSINewclip Technics2023-10-25
K223421MedCAD AccuPlan Orthopedics SystemMedcad2023-09-20
K231314Fine Osteotomy™Bodycad Laboratories, Inc.2023-06-02