← Back to catalogue

ReLine

FDA UDI

Class II (US FDA UDI)

by Nuvasive, Inc.

Identity

Trade Name
ReLine FDA UDI
Generic Name
Surgical instrument handle, non-torque-limiting FDA UDI
Device Name
RELINE Handle, Ratcheting Consol FDA UDI
Model / Reference
10001062 FDA UDI
Description
RELINE Handle, Ratcheting Consol FDA UDI

Identifiers

Primary DI / UDI-DI
00887517803139 FDA UDI
510(k) Number
K160989 FDA UDI
FDA Product Code
OSH FDA UDI
MNI FDA UDI
KWQ FDA UDI
NKB FDA UDI
KWP FDA UDI
MNH FDA UDI
GMDN Term
Surgical instrument handle, non-torque-limiting FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
888.3060 FDA UDI
888.3050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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: Surgical instrument handle, non-torque-limiting

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

Similar devices

Also classified as Surgical instrument handle, non-torque-limiting.

Cleared under the same submission

K160989 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Nuvasive, Inc.

Sources (1)

  • FDA UDI 17bb684c-d43b-4fe9-86de-135d9d12523d 35 fields · synced May 30, 2026