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BandLoc DUO

FDA UDI

Class II (US FDA UDI)

by Orthopediatrics Corp.

Identity

Trade Name
BandLoc DUO FDA UDI
Generic Name
Trans-facet-screw internal spinal fixation system, sterile FDA UDI
Device Name
BandLoc DUO 5.5/6.0 Sterile Implant FDA UDI
Model / Reference
10-1102-1555 FDA UDI
Description
BandLoc DUO 5.5/6.0 Sterile Implant FDA UDI

Identifiers

Catalog Number
10-1102-1555 FDA UDI
Primary DI / UDI-DI
00841132150627 FDA UDI
510(k) Number
K161267 FDA UDI
K200097 FDA UDI
FDA Product Code
OWI FDA UDI
GMDN Term
Trans-facet-screw internal spinal fixation system, sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3010 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
MRI Safety
MR Conditional FDA UDI

Category: Trans-facet-screw internal spinal fixation system, sterile

BandLoc DUO by Orthopediatrics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Trans-facet-screw internal spinal fixation system, sterile.

Cleared under the same submission

K161267 also covers:

K200097 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthopediatrics Corp.

Sources (1)

  • FDA UDI 94900513-3db2-42a8-8134-307ce9f1339a 35 fields · synced Jun 8, 2026