Baumer Locking Nail

FDA 510(k) K011504 · Baumer, S.A

Substantially Equivalent

510(k) numberK011504

Submission

Device name
Baumer Locking Nail
Applicant
Baumer, S.A
Mogi Mirim, Sao Paulo, BR
Received
May 16, 2001
Decision date
August 14, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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

Other 510(k)s with product code JDS

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K243608TRIGEN Stable Lock Nut & WasherJDS · Traditional Smith & Nephew, Inc.06/12/2025SE
K240061TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail SystemJDS · Traditional Smith & Nephew, Inc.09/20/2024SE
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

More from Smith & Nephew, Inc.

510(k)DeviceDecision
K003976Baumer Muller Hip ProsthesisJDI · Traditional 03/19/2001SE
K003975Baumer Cemented Hip ProsthesisJDI · Traditional 03/19/2001SE
K001571Baumer Femoral HeadJDI · Traditional 08/04/2000SE

Questions and answers

When was Baumer Locking Nail cleared by the FDA?

Baumer Locking Nail (K011504) received a 510(k) decision of Substantially Equivalent on August 14, 2001, 90 days after the submission was received.

What is the product code of K011504?

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