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Peri-Loc

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
PERI-LOC FDA UDI
Generic Name
Orthopaedic bone screw (non-sliding) FDA UDI
Device Name
PERI-LOC CABLE SADDLE SHORT TITANIUM FDA UDI
Model / Reference
71863475 FDA UDI
Description
PERI-LOC CABLE SADDLE SHORT TITANIUM FDA UDI

Identifiers

Catalog Number
71863475 FDA UDI
Primary DI / UDI-DI
00885556129555 FDA UDI
510(k) Number
K080434 FDA UDI
K210837 FDA UDI
K213126 FDA UDI
FDA Product Code
JDO FDA UDI
GMDN Term
Orthopaedic bone screw (non-sliding) 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

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthopaedic bone screw (non-sliding)

Peri-Loc by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone screw (non-sliding).

Cleared under the same submission

K080434 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI ef4c56a8-0812-4d1c-98ed-e31fe1effdc4 36 fields · synced Jun 8, 2026