CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUM

Screw, Fixation, Bone

AAP IMPLANTATE AG

The following data is part of a premarket notification filed by Aap Implantate Ag with the FDA for Cortical Screw 3.5, T15, Self-tapping, Titanium, Cortical Screw 4.5, T25, Self Tapping, Titanium.

Pre-market Notification Details

• Device ID: K141949
• 510k Number: K141949
• Device Name: CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUM
• Classification: Screw, Fixation, Bone
• Applicant: AAP IMPLANTATE AG LORENZWEG 5 Berlin, DE D-12099
• Contact: Christian Zietsch
• Correspondent: Christian Zietsch; AAP IMPLANTATE AG LORENZWEG 5 Berlin, DE D-12099
• Product Code: HWC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-07-18
• Decision Date: 2014-09-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04042409284861	K141949	000
04042409285011	K141949	000
04042409285028	K141949	000
04042409285035	K141949	000
04042409285042	K141949	000
04042409285059	K141949	000
04042409285066	K141949	000
04042409285073	K141949	000
04042409285080	K141949	000
04042409285097	K141949	000
04042409285103	K141949	000
04042409285110	K141949	000
04042409285004	K141949	000
04042409284991	K141949	000
04042409284878	K141949	000
04042409284892	K141949	000
04042409284908	K141949	000
04042409284915	K141949	000
04042409284922	K141949	000
04042409284939	K141949	000
04042409284946	K141949	000
04042409284953	K141949	000
04042409284960	K141949	000
04042409284977	K141949	000
04042409284984	K141949	000
04042409285127	K141949	000
04042409285134	K141949	000
04042409285301	K141949	000
04042409285318	K141949	000
04042409285325	K141949	000
04042409285332	K141949	000
04042409285349	K141949	000
04042409285356	K141949	000
04042409285363	K141949	000
04042409285370	K141949	000
04042409285387	K141949	000
04042409285394	K141949	000
04042409285400	K141949	000
04042409285295	K141949	000
04042409285288	K141949	000
04042409285165	K141949	000
04042409285172	K141949	000
04042409285189	K141949	000
04042409285196	K141949	000
04042409285202	K141949	000
04042409285219	K141949	000
04042409285226	K141949	000
04042409285233	K141949	000
04042409285257	K141949	000
04042409285264	K141949	000
04042409285271	K141949	000
04042409285417	K141949	000