INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR

Screw, Fixation, Bone

ACUFEX MICROSURGICAL, INC.

The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Interference-cannu-flex/silk Screws-screw Dr/g Wir.

Pre-market Notification Details

• Device ID: K921481
• 510k Number: K921481
• Device Name: INTERFERENCE-CANNU-FLEX/SILK SCREWS-SCREW DR/G WIR
• Classification: Screw, Fixation, Bone
• Applicant: ACUFEX MICROSURGICAL, INC. 130 FORBES BLVD. Mansfield, MA 02048
• Contact: Jeffrey Henderson
• Correspondent: Jeffrey Henderson; ACUFEX MICROSURGICAL, INC. 130 FORBES BLVD. Mansfield, MA 02048
• Product Code: HWC
• CFR Regulation Number: 888.3040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-03-30
• Decision Date: 1993-08-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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