PHANTOM FIBER BIOFIBER SUTURE— 510(k) K130422

Clearance details

Applicant

Tornier, Inc.

Product code

Product code NWJ

Device class

Class 2

Regulation

21 CFR 878.4494

Advisory panel

General, Plastic Surgery

Date received

2013-02-20

Decision date

2013-04-04

Decision

Substantially Equivalent

Clearance type

Special

Location

Bloomington, MN, US

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• Z-1374-2018 — Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMB000525 5.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMP000425 4.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMP000525 5.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMSB0110 1PK PHANTOM FIBER SZ 2 WHITE SMSB0110N lPK BIOFIBER SUTURE SZ 2 WHT NEEDLED SMSB0112 10 PK PHANTOM FIBER SZ 2 WHITE SMSB0112N 10 PK PHANTOM FIBER SUTURE SZ 2WHT NEEDLED SMSB0120 1PK PHANTOM FIBER SZ 2 VIOLET SMSB0120N lPK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB0122 10 PK PHANTOM FIBER SZ 2 VIOLET SMSB0122N 10 PK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB0130 1PK PHANTOM FIBER SZ 2 WHITE/VIOLET SMSB0132 10 PK PHANTOM FIBER SZ 2 WHITE/VIOLET Indications for use for the Phantom Fiber are: Phantom Fiber suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.Class II·Terminated·Tornier, Inc·20180208

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130422.