Endoskeleton® Tt

FDA UDI

Class II (US FDA UDI)

by Titan Spine, Inc.

Identity

Trade Name: ENDOSKELETON® TT FDA UDI
Generic Name: Bone curette, reusable FDA UDI
Device Name: Shaver, 8mm FDA UDI
Model / Reference: 4200-1108 FDA UDI
Description: Shaver, 8mm FDA UDI

Identifiers

Catalog Number: 4200-1108 FDA UDI
Primary DI / UDI-DI: 00191375003106 FDA UDI
510(k) Number: K083714 FDA UDI
FDA Product Code: MAX FDA UDI
GMDN Term: Bone curette, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 8.5 Inch FDA UDI
Height — 8 Millimeter FDA UDI

Category: Bone curette, reusable

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

Similar devices

Also classified as Bone curette, reusable.

Symmetry Bruns — SYMMETRY SURGICAL INC. · Class I
Ambler Surgical — Ambler Surgical, LLC · Class I
Spinal System — BIOMET SPINE LLC · Class I
Life Instruments — Life Instrument Corporation · Class I
Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
Novo Surgical — NOVO SURGICAL, INC. · Class I
Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
Volkmann Bone Curette Oval - Fig. 00 17 cm - 6 3/4" Scoop Size 4.4 mm Stainless Steel — SURTEX INSTRUMENTS LTD · Class I

Cleared under the same submission

K083714 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Titan Spine, Inc.

Sources (1)

FDA UDI 2c5981ed-a900-46ba-a23d-1cf61ea3be5d 37 fields · synced Jun 8, 2026