ReLine 10001220

by NuVasive, LLC

ReLine 10001220 is a Class II device made by NuVasive, LLC, cleared under FDA 510(k) K112709 on 9 Feb 2012 and listed in FDA GUDID since 22 Aug 2017 (UDI-DI 00887517764492), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00887517764492 UDI-DI	Date22 Aug 2017Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK112709	Date9 Feb 2012Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00887517764492
FDA 510(k) database 510(k) number K112709

Across registries

2 registries list this device

FDA 510(k) K112709 decided 9 Feb 2012 Active
FDA GUDID UDI-DI 00887517764492 listed 22 Aug 2017 Listed

Timeline

2 dated events

9 Feb 2012 Cleared FDA 510(k) K112709
22 Aug 2017 Listed FDA GUDID 00887517764492

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: ReLine
Generic name: Bone tap, reusable
Model / reference: 10001220

Primary DI / UDI-DI: 00887517764492
510(k) Number: K112709
FDA product code: ETN
GMDN term: Bone tap, reusable

Device class: Class II
Regulation number: 874.1820
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

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Properties

Sterilise before use
Prescription use
Lot / batch number

Other properties (12, all answered No)