OrthoMedFlex

FDA UDI

Class I (US FDA UDI)

by Orthomedflex Llc

Identity

Trade Name: OrthoMedFlex FDA UDI
Generic Name: Acetabular orthopaedic reamer FDA UDI
Device Name: Bridgeback Acetabular Reamer, Size 67mm FDA UDI
Model / Reference: 112152267 FDA UDI
Description: Bridgeback Acetabular Reamer, Size 67mm FDA UDI

Identifiers

Catalog Number: 112-152-267 FDA UDI
Primary DI / UDI-DI: M7161121522670 FDA UDI
FDA Product Code: HTO FDA UDI
GMDN Term: Acetabular orthopaedic reamer FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

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Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Acetabular orthopaedic reamer

The OrthoMedFlex Acetabular Reamer is a high-performance, reusable orthopaedic surgical instrument designed for precise cutting and resurfacing of the acetabulum in hip joint prostheses. Made from durable high-grade stainless steel alloy, this device features a unique hemispherical shell with an abrasive outer surface as the cutting head, allowing for effective removal of bone tissue. Available in various sizes, the OrthoMedFlex Acetabular Reamer is a valuable asset for orthopedic surgeons and implant companies alike.

Similar devices

Also classified as Acetabular orthopaedic reamer.

Acetabular Reamer Driver, Straight — TOTAL JOINT ORTHOPEDICS, INC. · Class I
Viant Medical, LLC — Viant Medical, LLC · Class I
ACETABULAR REAMER D53 mm HC — HPF SRL · Class I
Flexible Reamer Ø14 — NORMMED MEDİKAL SAN. VE TİC. A.Ş. · Class I
Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis — CORIN LTD · Class II
ACETABULAR REAMER D82 mm HC — HPF SRL · Class I
iTotal® Hip Replacement System — Conformis, Inc. · Class II
M.B.T. — DePuy Ireland UC · Class IIa

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

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Manufacturer

Manufacturer: Orthomedflex Llc

Sources (1)

FDA UDI 7416e2d9-b29a-4cde-9ee0-374b015f7bd6 35 fields · synced Jul 21, 2026