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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 hook FDA UDI
Device Name
RELINE-O Hook+LS, 9mm Offset Ang Right FDA UDI
Model / Reference
10301009P FDA UDI
Description
RELINE-O Hook+LS, 9mm Offset Ang Right FDA UDI

Identifiers

Primary DI / UDI-DI
00887517035165 FDA UDI
510(k) Number
K180498 FDA UDI
FDA Product Code
KWP FDA UDI
NKB FDA UDI
PML FDA UDI
GMDN Term
Bone-screw internal spinal fixation system hook FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3050 FDA UDI
888.3070 FDA UDI
888.3027 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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
Radiation Sterilization FDA UDI

Category: Bone-screw internal spinal fixation system hook

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 hook.

Cleared under the same submission

K180498 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 14dce567-2b71-4fbe-8feb-7a2aa47b5835 35 fields · synced May 29, 2026