SMV K-Wire and Pins

FDA UDI

Class I (US FDA UDI)

by OsteoCentric Technologies, Inc

Identity

Trade Name: SMV K-Wire and Pins FDA UDI
Generic Name: Orthopaedic bone pin, non-bioabsorbable FDA UDI
Device Name: Ø2.00 K-Wire, Trocar, Smooth, 150mm FDA UDI
Model / Reference: 130015 FDA UDI
Description: Ø2.00 K-Wire, Trocar, Smooth, 150mm FDA UDI

Identifiers

Catalog Number: 130015 FDA UDI
Primary DI / UDI-DI: 00816950025334 FDA UDI
510(k) Number: K182171 FDA UDI
FDA Product Code: FZX FDA UDI
GMDN Term: Orthopaedic bone pin, non-bioabsorbable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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 — 150 Millimeter FDA UDI
Outer Diameter — 2.00 Millimeter FDA UDI

Category: Orthopaedic bone pin, non-bioabsorbable

SMV K-Wire and Pins by OsteoCentric Technologies, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone pin, non-bioabsorbable.

Steinmann Pins, K-Wire, smooth — Gebr. Brasseler GmbH & Co. KG · Class II
KW03-310-18.A — newbox medical GmbH · Class IIb
Steinmann Pins, K-Wire, smooth — Gebr. Brasseler GmbH & Co. KG · Class II
IlluminOss — ILLUMINOSS MEDICAL INC. · Class II
XtraFix® External Fixation System — Zimmer, Inc. · Class II
CALIBRATED GUIDE WIRE, THREADED TROCAR POINT — Biomet Orthopedics, Inc. · Class II
TRAUMA FIXATION SYSTEMS — Biomet Orthopedics, Inc. · Class II
SMART TSF — Smith & Nephew, Inc. · Class II

Cleared under the same submission

K182171 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

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

Manufacturer

Manufacturer: OsteoCentric Technologies, Inc

Sources (1)

FDA UDI 5cb5f101-6122-4c0a-946f-472c2aa58fca 37 fields · synced Jun 1, 2026