Summit

FDA UDI

Class II (US FDA UDI)

by Depuy Spine, Inc.

Identity

Trade Name: SUMMIT FDA UDI
Generic Name: Bone-screw internal spinal fixation system, non-sterile FDA UDI
Device Name: SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 3.5 x 28mm FDA UDI
Model / Reference: 174618728 FDA UDI
Description: SUMMIT SI OCT SPINAL FIXATION SYSTEM MINI POLYAXIAL BONE SCREW 3 x 3.5 x 28mm FDA UDI

Identifiers

Catalog Number: 174618728 FDA UDI
Primary DI / UDI-DI: 10705034022031 FDA UDI
510(k) Number: K030103 FDA UDI
K151885 FDA UDI
K190895 FDA UDI
FDA Product Code: KWP FDA UDI
MNI FDA UDI
NKG FDA UDI
GMDN Term: Bone-screw internal spinal fixation system, non-sterile FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3050 FDA UDI
888.3070 FDA UDI
888.3075 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Summit by Depuy Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K151885 also covers:

K190895 also covers:

MOUNTAINEER — Medos International Sàrl

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: Depuy Spine, Inc.

Sources (1)

FDA UDI 891b32a4-81da-4585-9400-f6607f8254c3 37 fields · synced May 31, 2026