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TMJ Concepts Patient-Fitted Temporomandibular Joint (TMJ) st

FDA premarket approval P980052/S012 · decided 2023-08-22

Approval details

PMA number
P980052
Supplement
S012
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
TMJ Concepts Patient-Fitted Temporomandibular Joint (TMJ) st
Generic name
Joint, temporomandibular, implant
Applicant
Stryker Leibinger, GmbH & Co KG
Date received
2023-08-04
Decision date
2023-08-22
Days to decision
18 days
Decision code
OK30
Product code
LZD
Advisory committee
Dental
Expedited review
No
Location
Freiburg
Statement
Implementation of SAP ERP System to replace Factory Edge

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510(k) clearances by this applicant

RecordFirmDate
RibPlate System (K261054)Stryker Leibinger GmbH & Co KG2026-07-01
MEDPOR Customized Implant Kit (K254233)Stryker Leibinger GmbH & Co KG2026-03-12
Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor (K253623)Stryker Leibinger GmbH & Co KG2026-02-19
Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories (K252871)Stryker Leibinger GmbH & Co KG2026-02-06
SternalPlate Expansion (K243491)Stryker Leibinger GmbH & Co KG2024-12-11
Q Guidance System; Mako Spine System; (K241517)Stryker Leibinger GmbH & Co KG2024-08-27
Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories (K241171)Stryker Leibinger GmbH & Co KG2024-07-25
MRI Universal (K240651)Stryker Leibinger GmbH & Co KG2024-07-12