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Tsi

FDA UDI

Class II (US FDA UDI)

by Tedan Surgical Innovations, L.l.c.

Identity

Trade Name
TSI FDA UDI
Generic Name
Lumbar interspinous decompression instrument set, single-use FDA UDI
Device Name
Insulated Dilator Set, 7, 12, & 15 MM, Sterile FDA UDI
Model / Reference
ML-0444S FDA UDI
Description
Insulated Dilator Set, 7, 12, & 15 MM, Sterile FDA UDI

Identifiers

Primary DI / UDI-DI
00851797006436 FDA UDI
510(k) Number
K140088 FDA UDI
FDA Product Code
PDQ FDA UDI
GMDN Term
Lumbar interspinous decompression instrument set, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.1820 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

No

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

Dimensions & Sizes

Size
Width — 14.9 Millimeter FDA UDI
Width — 12 Millimeter FDA UDI
Width — 7 Millimeter FDA UDI

Category: Lumbar interspinous decompression instrument set, single-use

Tsi by Tedan Surgical Innovations, L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Lumbar interspinous decompression instrument set, single-use.

Cleared under the same submission

K140088 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tedan Surgical Innovations, L.l.c.

Sources (1)

  • FDA UDI e11f2bf9-20da-41d8-9a5c-12619b00e91b 35 fields · synced Jun 8, 2026