BNF

FDA 510(k) K021782 · Aap Implantate AG

Substantially Equivalent

510(k) numberK021782

Submission

Device name
BNF
Applicant
Aap Implantate AG
Berlin, DE
Received
May 30, 2002
Decision date
August 26, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JDS – Nail, Fixation, Bone
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Specialty
Orthopedic
Implant
Yes

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K243608TRIGEN Stable Lock Nut & WasherJDS · Traditional Smith & Nephew, Inc.06/12/2025SE
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K241804TRIGEN INTERTAN 10S Nail SystemJDS · Traditional Smith & Nephew, Inc.08/22/2024SE
K233150NET BRAND Osteosynthesis Nailing SystemJDS · Traditional Narang Medical , Ltd.02/20/2024SE
K230761TRIGEN META-NAIL Nail SystemJDS · Traditional Smith & Nephew, Inc.06/14/2023SE
K201336DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0…JDS · Traditional Synthes (USA) Products, LLC09/03/2020SE
K192003Auxein Nailing SystemJDS · Traditional Auxein Medical Private Limited06/10/2020SE
K193533WIN Flexible Nail SystemJDS · Traditional Biomet, Inc.02/20/2020SE
K141737Conventus PHS SystemJDS · Traditional Conventus Orthopaedics, Inc.04/08/2015SE
K123948China Nails and AccessoriesJDS · Traditional Smith & Nephew, Inc.03/14/2013SE

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K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ®…HRS · Traditional 11/22/2016SE
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Questions and answers

When was BNF cleared by the FDA?

BNF (K021782) received a 510(k) decision of Substantially Equivalent on August 26, 2002, 88 days after the submission was received.

What is the product code of K021782?

The FDA product code is JDS – Nail, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.