Nautilus Spinal System 148-310

by Life Spine, Inc.

Nautilus Spinal System 148-310 is a Class II device made by Life Spine, Inc., cleared under FDA 510(k) K111953 on 7 Aug 2012 and listed in FDA GUDID since 6 Nov 2019 (UDI-DI 00190837054410), active as of 23 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 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00190837054410 UDI-DI	Date6 Nov 2019Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK111953	Date7 Aug 2012Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00190837054410
FDA 510(k) database 510(k) number K111953

Across registries

2 registries list this device

FDA 510(k) K111953 decided 7 Aug 2012 Active
FDA GUDID UDI-DI 00190837054410 listed 6 Nov 2019 Listed

Timeline

2 dated events

7 Aug 2012 Cleared FDA 510(k) K111953
6 Nov 2019 Listed FDA GUDID 00190837054410

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Nautilus Spinal System
Generic name: Bone tap, reusable
Model / Ref / Catalog: 148-310

Primary DI / UDI-DI: 00190837054410
510(k) Number: K111953
FDA product code: NKB
GMDN term: Bone tap, reusable

Device class: Class II
Regulation number: 888.3070
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)