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Implant and Instrument Set 7.0mm

FDA UDI

Class II (US FDA UDI)

by Ortho Outcomes, Llc

Identity

Trade Name
Implant and Instrument Set 7.0mm FDA UDI
Generic Name
Orthopaedic bone bolt FDA UDI
Device Name
Bone Bolt System Implant and Instrument Set 7.0mm FDA UDI
Model / Reference
104-0425 FDA UDI
Description
Bone Bolt System Implant and Instrument Set 7.0mm FDA UDI

Identifiers

Primary DI / UDI-DI
00850072364001 FDA UDI
FDA Product Code
HWC FDA UDI
GMDN Term
Orthopaedic bone bolt 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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 bolt

Implant and Instrument Set 7.0mm by Ortho Outcomes, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone bolt.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ortho Outcomes, Llc

Sources (1)

  • FDA UDI f748ca1d-3900-4b25-ae58-bd485503357f 33 fields · synced Jun 1, 2026