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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
Bone file/rasp, manual, reusable FDA UDI
Device Name
Straight Tooth Rasp, 9mm FDA UDI
Model / Reference
3210-0001 FDA UDI
Description
Straight Tooth Rasp, 9mm FDA UDI

Identifiers

Catalog Number
3210-0001 FDA UDI
Primary DI / UDI-DI
00191375028352 FDA UDI
510(k) Number
K102067 FDA UDI
FDA Product Code
MAX FDA UDI
GMDN Term
Bone file/rasp, manual, 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 — 14 Inch FDA UDI
Width — 9 Millimeter 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 57ce32e5-7fa4-4a67-9076-0795e7c5e3b8 38 fields · synced May 31, 2026