SYNTHES MAXILLOFACIAL TITANIUM MICRO SET

Plate, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Maxillofacial Titanium Micro Set.

Pre-market Notification Details

• Device ID: K912932
• 510k Number: K912932
• Device Name: SYNTHES MAXILLOFACIAL TITANIUM MICRO SET
• Classification: Plate, Fixation, Bone
• Applicant: SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301
• Contact: Diane Cochet-wynant
• Correspondent: Diane Cochet-wynant; SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301
• Product Code: HRS
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-07-05
• Decision Date: 1991-09-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
H980420100	K912932	000
H980400607E0	K912932	000
H980400606E0	K912932	000
H980400605E0	K912932	000
H980400604E0	K912932	000
H980400603E0	K912932	000
H980400602E0	K912932	000
H980400514E0	K912932	000
H980400512E0	K912932	000
H980400511E0	K912932	000
H980400510E0	K912932	000
H980400608E0	K912932	000
H980400609E0	K912932	000
H980400610E0	K912932	000
H9804200700	K912932	000
H980420060	K912932	000
H980420050	K912932	000
H980420040	K912932	000
H980420020	K912932	000
H980420010	K912932	000
H980420000	K912932	000
H980400614E0	K912932	000
H980400612E0	K912932	000
H980400611E0	K912932	000
H980400509E0	K912932	000
H980400508E0	K912932	000
H980400507E0	K912932	000
H980400405E0	K912932	000
H980400404E0	K912932	000
H980400403E0	K912932	000
H980400402E0	K912932	000
H6794213350	K912932	000
H6794213340	K912932	000
H6794213330	K912932	000
H6794213210	K912932	000
H6794213200	K912932	000
H6794213120	K912932	000
H980400406E0	K912932	000
H980400408E0	K912932	000
H980400462E0	K912932	000
H980400506E0	K912932	000
H980400505E0	K912932	000
H980400504E0	K912932	000
H980400503E0	K912932	000
H980400502E0	K912932	000
H980400468E0	K912932	000
H980400466E0	K912932	000
H980400465E0	K912932	000
H980400464E0	K912932	000
H980400463E0	K912932	000
H6794213060	K912932	000
H980420210	K912932	000
20887587044337	K912932	000
20887587044054	K912932	000
H9804005100	K912932	000
20887587044016	K912932	000
20887587043996	K912932	000
20887587043972	K912932	000
20887587043958	K912932	000
20887587043934	K912932	000
20887587043910	K912932	000
20887587043897	K912932	000
20887587043873	K912932	000
20887587044078	K912932	000
20887587044092	K912932	000
20887587044115	K912932	000
20887587044313	K912932	000
20887587044290	K912932	000
20887587044276	K912932	000
20887587044252	K912932	000
20887587044238	K912932	000
20887587044214	K912932	000
20887587044191	K912932	000
20887587044177	K912932	000
20887587044153	K912932	000
20887587044139	K912932	000
20887587043422	K912932	000
20887587043385	K912932	000
20887587043361	K912932	000
H980420710	K912932	000
H980420700	K912932	000
H980420680	K912932	000
H9804206310	K912932	000
H980420630	K912932	000
H980420620	K912932	000
H980420550	K912932	000
H980420540	K912932	000
H980420450	K912932	000
H980420440	K912932	000
H980420810	K912932	000
H980420840	K912932	000
H980420850	K912932	000
20887587043347	K912932	000
20887587043323	K912932	000
20887587043309	K912932	000
20887587042715	K912932	000
20887587042678	K912932	000
20887587042654	K912932	000
20887587042630	K912932	000
20887587042616	K912932	000
H9804004020	K912932	000
H9804210010	K912932	000
H980420400	K912932	000