5ms

FDA UDI

Class II (US FDA UDI)

by In2Bones, USA

Identity

Trade Name: 5MS FDA UDI
Generic Name: Surgical implant template, reusable FDA UDI
Device Name: 5MS, PSEUDO JONES PLATE, Long FDA UDI
Model / Reference: P60 ST051 FDA UDI
Description: 5MS, PSEUDO JONES PLATE, Long FDA UDI

Identifiers

Catalog Number: P60 ST051 FDA UDI
Primary DI / UDI-DI: 00810021864037 FDA UDI
510(k) Number: K170518 FDA UDI
FDA Product Code: HRS FDA UDI
GMDN Term: Surgical implant template, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Surgical implant template, reusable

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

Similar devices

Also classified as Surgical implant template, reusable.

Newclip Instruments — NEWCLIP TECHNICS · Class I
Titan Reverse Shoulder System — Smith & Nephew, Inc. · Class I
Legion — Smith & Nephew, Inc. · Class II
LIGAFIX® — S.B.M. SAS · Class I
EVOS — Smith & Nephew, Inc. · Class I
Tranquil-C™ — NEXUS SPINE, L.L.C. · Class I
VFT — Ldr Spine USA · Class II
Tranquil-C™ — NEXUS SPINE, L.L.C. · Class I

Cleared under the same submission

K170518 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: In2Bones, USA

Sources (1)

FDA UDI 8442178d-47ed-4a66-ac80-6805261b7986 36 fields · synced May 31, 2026