FIXATION WIRE

Pin, Fixation, Smooth

SIMPEX, INC.

The following data is part of a premarket notification filed by Simpex, Inc. with the FDA for Fixation Wire.

Pre-market Notification Details

• Device ID: K911505
• 510k Number: K911505
• Device Name: FIXATION WIRE
• Classification: Pin, Fixation, Smooth
• Applicant: SIMPEX, INC. 13775 SW LARCH PLACE, SUITE 26 Beaverton, OR 97005
• Contact: Richard Gorski
• Correspondent: Richard Gorski; SIMPEX, INC. 13775 SW LARCH PLACE, SUITE 26 Beaverton, OR 97005
• Product Code: HTY
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-04-04
• Decision Date: 1991-04-12

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B068TK028121	K911505	000
B068KD05461	K911505	000
B068KD0545S1	K911505	000
B068KD05451	K911505	000
B068KD0544S1	K911505	000
B068KD05441	K911505	000
B068KD05412S1	K911505	000
B068KD054121	K911505	000
B068KD0459S1	K911505	000
B068KD04591	K911505	000
B068KD0456S1	K911505	000
B068KD0546S1	K911505	000
B068KD05491	K911505	000
B068KD0549S1	K911505	000
B068KD0629S1	K911505	000
B068KD06291	K911505	000
B068KD0626S1	K911505	000
B068KD06261	K911505	000
B068KD0625S1	K911505	000
B068KD06251	K911505	000
B068KD0624S1	K911505	000
B068KD06241	K911505	000
B068KD06212S1	K911505	000
B068KD062121	K911505	000
B068KD04561	K911505	000
B068KD0455S1	K911505	000
B068KD04551	K911505	000
B068KD035121	K911505	000
B068KD0289S1	K911505	000
B068KD02891	K911505	000
B068KD0286S1	K911505	000
B068KD02861	K911505	000
B068KD0285S1	K911505	000
B068KD02851	K911505	000
B068KD0284S1	K911505	000
B068KD02841	K911505	000
B068KD02812S1	K911505	000
B068KD03512S1	K911505	000
B068KD03541	K911505	000
B068KD0354S1	K911505	000
B068KD0454S1	K911505	000
B068KD04541	K911505	000
B068KD04512S1	K911505	000
B068KD045121	K911505	000
B068KD0359S1	K911505	000
B068KD03591	K911505	000
B068KD0356S1	K911505	000
B068KD03561	K911505	000
B068KD0355S1	K911505	000
B068KD03551	K911505	000
B068KD028121	K911505	000
B068TK02812S1	K911505	000
B068TK0629S1	K911505	000
B068TK05461	K911505	000
B068TK0545S1	K911505	000
B068TK05451	K911505	000
B068TK0544S1	K911505	000
B068TK05441	K911505	000
B068TK05412S1	K911505	000
B068TK054121	K911505	000
B068TK0459S1	K911505	000
B068TK04591	K911505	000
B068TK0456S1	K911505	000
B068TK0546S1	K911505	000
B068TK05491	K911505	000
B068TK0549S1	K911505	000
B068TK06291	K911505	000
B068TK0626S1	K911505	000
B068TK06261	K911505	000
B068TK0625S1	K911505	000
B068TK06251	K911505	000
B068TK0624S1	K911505	000
B068TK06241	K911505	000
B068TK062149S1	K911505	000
B068TK06212S1	K911505	000
B068TK062121	K911505	000
B068TK04561	K911505	000
B068TK0455S1	K911505	000
B068TK04551	K911505	000
B068TK035149S1	K911505	000
B068TK03512S1	K911505	000
B068TK035121	K911505	000
B068TK0289S1	K911505	000
B068TK02891	K911505	000
B068TK0286S1	K911505	000
B068TK02861	K911505	000
B068TK0285S1	K911505	000
B068TK02851	K911505	000
B068TK0284S1	K911505	000
B068TK03541	K911505	000
B068TK0354S1	K911505	000
B068TK03551	K911505	000
B068TK0454S1	K911505	000
B068TK04541	K911505	000
B068TK045149S1	K911505	000
B068TK04512S1	K911505	000
B068TK045121	K911505	000
B068TK0359S1	K911505	000
B068TK03591	K911505	000
B068TK0356S1	K911505	000
B068TK03561	K911505	000
B068TK0355S1	K911505	000
B068TK02841	K911505	000