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5ms

FDA UDI

Class II (US FDA UDI)

by In2Bones, USA

Identity

Trade Name
5MS FDA UDI
Generic Name
Surgical implant/trial-implant/sizer holder, reusable FDA UDI
Device Name
5MS, LATERAL NECK PLATE, 8H, L, TRIAL FDA UDI
Model / Reference
P06 N1023 FDA UDI
Description
5MS, LATERAL NECK PLATE, 8H, L, TRIAL FDA UDI

Identifiers

Catalog Number
P06 N1023 FDA UDI
Primary DI / UDI-DI
00817906028256 FDA UDI
510(k) Number
K170518 FDA UDI
FDA Product Code
HWC FDA UDI
HRS FDA UDI
GMDN Term
Surgical implant/trial-implant/sizer holder, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
888.3030 FDA UDI
Commercial Distribution
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

Category: Surgical implant/trial-implant/sizer holder, reusable

5ms by In2Bones, USA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical implant/trial-implant/sizer holder, reusable.

Cleared under the same submission

K170518 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
In2Bones, USA

Sources (1)

  • FDA UDI e77a931b-0372-4c9e-a1e1-72afb2aa3fc3 36 fields · synced Jun 8, 2026