Poly Plug Cement Restrictor

FDA 510(k) K840242 · Latham Manufacturer

Substantially Equivalent

510(k) numberK840242

Submission

Device name
Poly Plug Cement Restrictor
Applicant
Latham Manufacturer
Walker, MI, US
Received
January 20, 1984
Decision date
May 30, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

510(k)DeviceApplicantDecision
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

Questions and answers

When was Poly Plug Cement Restrictor cleared by the FDA?

Poly Plug Cement Restrictor (K840242) received a 510(k) decision of Substantially Equivalent on May 30, 1984, 131 days after the submission was received.

What is the product code of K840242?

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