Simpex Steinmann Pin

FDA UDI

Class II (US FDA UDI)

by Simpex Medical, Inc.

Identity

Trade Name: Simpex Steinmann Pin FDA UDI
Generic Name: Orthopaedic bone pin, non-bioabsorbable FDA UDI
Device Name: Smooth Steinmann Pin, Double Trocar Tip; 3/32" DIA x 12" LG; Material: 316L Stainless Steel FDA UDI
Model / Reference: T-093-12 FDA UDI
Description: Smooth Steinmann Pin, Double Trocar Tip; 3/32" DIA x 12" LG; Material: 316L Stainless Steel FDA UDI

Identifiers

Catalog Number: T-093-12 FDA UDI
Primary DI / UDI-DI: B068T093121 FDA UDI
510(k) Number: K911452 FDA UDI
FDA Product Code: HTY FDA UDI
GMDN Term: Orthopaedic bone pin, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 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 — 305 Millimeter FDA UDI
Outer Diameter — 2.4 Millimeter FDA UDI

Category: Orthopaedic bone pin, non-bioabsorbable

Simpex Steinmann Pin by Simpex Medical, Inc. — Class II — 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

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: Simpex Medical, Inc.

Sources (1)

FDA UDI b1d373a3-422a-4561-b201-e71409311630 37 fields · synced Jun 8, 2026