Neoview®

FDA UDI

Class I (US FDA UDI)

by In2bones

Identity

Trade Name: NEOVIEW® FDA UDI
Generic Name: Surgical implant template, reusable FDA UDI
Model / Reference: P03 00121 FDA UDI

Identifiers

Catalog Number: P03 00121 FDA UDI
Primary DI / UDI-DI: 03760225715888 FDA UDI
510(k) Number: K160995 FDA UDI
FDA Product Code: HWT FDA UDI
GMDN Term: Surgical implant template, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4800 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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 56.80 Millimeter FDA UDI
Width — 25.80 Millimeter FDA UDI

Category: Surgical implant template, reusable

Neoview® by In2bones — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Tranquil-C™ — NEXUS SPINE, L.L.C. · Class I

Cleared under the same submission

K160995 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 I	Pending data

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Manufacturer

Manufacturer: In2bones

Sources (1)

FDA UDI 1d1daae8-a6bd-4b12-b604-5046368cb41f 36 fields · synced May 30, 2026