Inserteo, Meta.-Phal.&Thumb Carpo-Meta

FDA 510(k) K771072 · Depuy, Inc.

Substantially Equivalent

510(k) numberK771072

Submission

Device name
Inserteo, Meta.-Phal.&Thumb Carpo-Meta
Applicant
Depuy, Inc.
Mchenry, IL, US
Received
June 14, 1977
Decision date
June 27, 1977
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HXO – Pusher, Socket
Device class
Class I (low risk)
Regulation
21 CFR 888.4540
Specialty
Orthopedic

Other 510(k)s with product code HXO

510(k)DeviceApplicantDecision
K885305Acetabular Cup Pusher/ImpactorHXO · Traditional Cobot Medical Corp.02/08/1989SE
K803165Acetabular Cement CompressorHXO · Traditional Zimmer, Inc.12/31/1980SE

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K041085LPS (Limb Preservation System) Lower Extremity Dovetail IntercalaryJWH · Traditional 07/22/2004SE
K033959LPSJWH · Traditional 07/01/2004SE
K040544Duraloc Option Acetabular Cup System, Models 1599-01-044 to -066, 1599-11-044 to -062…LPH · Traditional 05/28/2004SE
K021478Delta ShoulderPHX · Traditional 11/18/2003SE
K033329Depuy Ace Universal and Troch Entry Femoral Nail SystemsHSB · Traditional 11/14/2003SE
K032151Depuy Sigma Tibial Inserts and Co-Cr Tibial TraysJWH · Special 09/26/2003SE
K020541Agility Ankle Revision ProsthesisHSN · Traditional 05/20/2002SE
K011810Orthogenesis LPS Proximal Tibial Replacement and Orthogenesis LPS Tibial BearingKRO · Traditional 09/07/2001SE

Questions and answers

When was Inserteo, Meta.-Phal.&Thumb Carpo-Meta cleared by the FDA?

Inserteo, Meta.-Phal.&Thumb Carpo-Meta (K771072) received a 510(k) decision of Substantially Equivalent on June 27, 1977, 13 days after the submission was received.

What is the product code of K771072?

The FDA product code is HXO – Pusher, Socket, a Class I (low risk) device regulated under 21 CFR 888.4540.