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Arx

FDA UDI

Class II (US FDA UDI)

by Life Spine, Inc.

Identity

Trade Name
Arx FDA UDI
Generic Name
Bone-screw internal spinal fixation system, non-sterile FDA UDI
Device Name
Full CoCr Assembly NC, 5.5 x 55 Long FDA UDI
Model / Reference
13-5555-13 FDA UDI
Description
Full CoCr Assembly NC, 5.5 x 55 Long FDA UDI

Identifiers

Catalog Number
13-5555-13 FDA UDI
Primary DI / UDI-DI
00190837035594 FDA UDI
510(k) Number
K061600 FDA UDI
FDA Product Code
NKB FDA UDI
GMDN Term
Bone-screw internal spinal fixation system, non-sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 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: Bone-screw internal spinal fixation system, non-sterile

Arx by Life Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-screw internal spinal fixation system, non-sterile.

Cleared under the same submission

K061600 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Life Spine, Inc.

Sources (1)

  • FDA UDI 68cc8c82-5b7a-41ab-b53a-b6b50905ca78 35 fields · synced May 31, 2026