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ReLine

FDA UDI

Class II (US FDA UDI)

by Nuvasive, Inc.

Identity

Trade Name
ReLine FDA UDI
Generic Name
Bone-screw internal spinal fixation system connector FDA UDI
Device Name
RSS Cross Conn, 25mm Fixed 4.5 Rod FDA UDI
Model / Reference
10145325 FDA UDI
Description
RSS Cross Conn, 25mm Fixed 4.5 Rod FDA UDI

Identifiers

Primary DI / UDI-DI
00887517801906 FDA UDI
510(k) Number
K170126 FDA UDI
FDA Product Code
NKB FDA UDI
KWP FDA UDI
KWQ FDA UDI
GMDN Term
Bone-screw internal spinal fixation system connector FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
888.3050 FDA UDI
888.3060 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

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 connector

ReLine by Nuvasive, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-screw internal spinal fixation system connector.

Cleared under the same submission

K170126 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nuvasive, Inc.

Sources (1)

  • FDA UDI 76fb9b4d-7843-4443-80f0-c7a8af714cd1 35 fields · synced May 30, 2026