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TK® Ti-KNOT®

FDA UDI

Class I (US FDA UDI)

by LSI Solutions, Inc.

Identity

Trade Name
TK® Ti-KNOT® FDA UDI
Generic Name
Suture clasp, non-bioabsorbable FDA UDI
Device Name
TK® Ti-KNOT® DEVICE FDA UDI
Model / Reference
030404 FDA UDI
Description
TK® Ti-KNOT® DEVICE FDA UDI

Identifiers

Catalog Number
030404 FDA UDI
Primary DI / UDI-DI
00850200006094 FDA UDI
510(k) Number
K100593 FDA UDI
FDA Product Code
HCF FDA UDI
GMDN Term
Suture clasp, non-bioabsorbable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 5 Millimeter FDA UDI

Category: Suture clasp, non-bioabsorbable

TK® Ti-KNOT® by LSI Solutions, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Suture clasp, non-bioabsorbable.

Cleared under the same submission

K100593 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
LSI Solutions, Inc.

Sources (1)

  • FDA UDI f25d2234-6b51-479b-9dfa-a9f87b8c08d9 37 fields · synced May 30, 2026