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Endoskeleton® To

FDA UDI

Class II (US FDA UDI)

by Titan Spine, Inc.

Identity

Trade Name
ENDOSKELETON® TO FDA UDI
Generic Name
Instrument tray, reusable FDA UDI
Device Name
Odd Size Trays FDA UDI
Model / Reference
3900-1011 FDA UDI
Description
Odd Size Trays FDA UDI

Identifiers

Catalog Number
3900-1011 FDA UDI
Primary DI / UDI-DI
00191375004981 FDA UDI
510(k) Number
K102067 FDA UDI
FDA Product Code
MAX FDA UDI
GMDN Term
Instrument tray, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 21 Inch FDA UDI
Width — 10 Inch FDA UDI
Height — 4 Inch FDA UDI

Endoskeleton® To by Titan Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K102067 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Titan Spine, Inc.

Sources (1)

  • FDA UDI 7950bbb8-0b29-4e1c-8f7c-d8b6d2d02830 38 fields · synced May 31, 2026