Acetabular reamer ø75mm

FDA UDI

Class I (US FDA UDI)

by Incipio Devices

Identity

Trade Name: Acetabular reamer ø75mm FDA UDI
Generic Name: Acetabular orthopaedic reamer FDA UDI
Device Name: Acetabular reamer for hip arthroplasty FDA UDI
Model / Reference: 50143975 FDA UDI
Description: Acetabular reamer for hip arthroplasty FDA UDI

Identifiers

Catalog Number: 50143975 FDA UDI
Primary DI / UDI-DI: 07630055302397 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

Yes

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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 75 Millimeter FDA UDI

Category: Acetabular orthopaedic reamer

Acetabular reamer ø75mm by Incipio Devices — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Acetabular orthopaedic reamer.

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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: Incipio Devices

Sources (1)

FDA UDI fcef20ee-fe1e-41f8-9f39-dd5902a32e41 35 fields · synced May 30, 2026