PMA P090029S007

Device: PRESTIGE LP CERVICAL DISC STREAMLINED INSTRUMENTS
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P090029
Supplement: S007
Product code: MJO
Decision date: 2017-04-03
Classification: Prosthesis, Intervertebral Disc
Generic name: Prosthesis, intervertebral disc
Approval order statement: Approval for the Prestige LP Cervical Disc streamlined instrument set, which primarily includes updates to the implant trial, drill guide, and rail punch instruments.

Current openFDA PMA Record#

Device: PRESTIGE LP CERVICAL DISC STREAMLINED INSTRUMENTS
Applicant: Medtronic Sofamor Danek USA, Inc.
PMA number: P090029
Supplement: S007
Product code: MJO
Generic name: Prosthesis, intervertebral disc
Decision date: 2017-04-03
Decision code: APPR
Date received: 2016-12-22
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the Prestige LP Cervical Disc streamlined instrument set, which primarily includes updates to the implant trial, drill guide, and rail punch instruments.