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Nbx

FDA UDI

Class II (US FDA UDI)

by NUTEK Orthopaedics, Inc

Identity

Trade Name
NBX FDA UDI
Generic Name
External orthopaedic fixation system, single-use, sterile FDA UDI
Device Name
NON-BRIDGING EXTERNAL FIXATOR HAND LONG FDA UDI
Model / Reference
8207-00-00 FDA UDI
Description
NON-BRIDGING EXTERNAL FIXATOR HAND LONG FDA UDI

Identifiers

Catalog Number
8207-00-00 FDA UDI
Primary DI / UDI-DI
B488820700000 FDA UDI
FDA Product Code
KTT FDA UDI
JEC FDA UDI
LXT FDA UDI
GMDN Term
External orthopaedic fixation system, single-use, sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
888.3040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Category: External orthopaedic fixation system, single-use, sterile

Nbx by NUTEK Orthopaedics, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External orthopaedic fixation system, single-use, sterile.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
NUTEK Orthopaedics, Inc

Sources (1)

  • FDA UDI a406a595-eede-4833-b396-a9b85edc71cf 35 fields · synced Jun 8, 2026