ReLine

FDA UDI

Class II (US FDA UDI)

by Nuvasive, Inc.

Identity

Trade Name: ReLine FDA UDI
Generic Name: Bone tap, reusable FDA UDI
Device Name: RELINE Tap, 4.5mm Cannulated Consol XT FDA UDI
Model / Reference: 10001056 FDA UDI
Description: RELINE Tap, 4.5mm Cannulated Consol XT FDA UDI

Identifiers

Primary DI / UDI-DI: 00887517801708 FDA UDI
510(k) Number: K160989 FDA UDI
FDA Product Code: OSH FDA UDI
MNI FDA UDI
MNH FDA UDI
KWP FDA UDI
NKB FDA UDI
KWQ FDA UDI
GMDN Term: Bone tap, reusable 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone tap, reusable

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

Similar devices

Also classified as Bone tap, reusable.

BIOSURE — Smith & Nephew, Inc. · Class I
NobelActive® — Nobel Biocare AG · Class I
CORTICAL TAP — Biomet Orthopedics, Inc. · Class I
PressON™ — NEXUS SPINE, L.L.C. · Class I
Insite — TORNIER, INC. · Class I
Mariner MIS — SeaSpine Orthopedics Corporation · Class I
Response 5.5/6.0 Spine System — ORTHOPEDIATRICS CORP. · Class I
Nautilus Spinal System — Life Spine, Inc. · Class II

Cleared under the same submission

K160989 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Nuvasive, Inc.

Sources (1)

FDA UDI 16403e6c-03f3-48c6-bf69-ab18e3b3bb3e 35 fields · synced May 30, 2026