Imsi/Metripond Gripper Plate

FDA 510(k) K843370 · Intl. Management Services, Inc.

Substantially Equivalent

510(k) numberK843370

Submission

Device name
Imsi/Metripond Gripper Plate
Applicant
Intl. Management Services, Inc.
Lincoln, NE, US
Received
August 28, 1984
Decision date
January 23, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

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

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K261511Xpert AnkleHRS · Traditional Newclip Technics07/28/2026SE
K261406Versalock Proximal Tibial Plating SystemHRS · Traditional GM Dos Reis Industria e Comercio Ltda.07/21/2026SE
K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…HRS · Special TriMed, Inc.07/16/2026SE
K261191Alians Elbow SHRS · Traditional Newclip Technics07/08/2026SE
K261054RibPlate SystemHRS · Traditional Stryker Leibinger GmbH & Co KG07/01/2026SE
K261351SALGINA 2.5mm Distal Radius SystemHRS · Traditional Bonebridge AG06/26/2026SE

More from Bonebridge AG

510(k)DeviceDecision
K873612Imsi, Vital CallIQA · Traditional 11/23/1987SE
K872876Imsi/Easy Float MattressFOH · Traditional 10/13/1987SE
K830339Imsi/Metripond Hand Operating TableFSE · Traditional 04/12/1983SE

Questions and answers

When was Imsi/Metripond Gripper Plate cleared by the FDA?

Imsi/Metripond Gripper Plate (K843370) received a 510(k) decision of Substantially Equivalent on January 23, 1985, 148 days after the submission was received.

What is the product code of K843370?

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