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Orbitum VI Staple

FDA UDI

Class II (US FDA UDI)

by CPM Medical Consultants, LLC

Identity

Trade Name
Orbitum VI Staple FDA UDI
Generic Name
Orthopaedic bone staple, non-adjustable, non-sterile FDA UDI
Device Name
12mm Hourglass Staple FDA UDI
Model / Reference
Rev A FDA UDI
Description
12mm Hourglass Staple FDA UDI

Identifiers

Catalog Number
FO-1001-1208 FDA UDI
Primary DI / UDI-DI
B565FO100112080 FDA UDI
510(k) Number
K173693 FDA UDI
FDA Product Code
JDR FDA UDI
GMDN Term
Orthopaedic bone staple, non-adjustable, non-sterile 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic bone staple, non-adjustable, non-sterile

Orbitum VI Staple by CPM Medical Consultants, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone staple, non-adjustable, non-sterile.

Cleared under the same submission

K173693 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
CPM Medical Consultants, LLC

Sources (1)

  • FDA UDI ceea250d-0eff-4b87-960d-92e5a6a5bd4f 36 fields · synced Jun 1, 2026