SureMAX-SA 1

by Additive Implants, Inc. 34 variants

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00817662025803 UDI-DI	Date30 Sep 2021Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK211111	Date16 Jul 2021Decided	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: SureMAX-SA
Generic name: Metallic spinal interbody fusion cage
Model / Ref / Catalog: 1, 1022-702

Primary DI / UDI-DI: 00817662025803
510(k) Number: K211111
FDA product code: LYQ
GMDN term: Metallic spinal interbody fusion cage

Device class: Class I
Regulation number: 888.4540
GUDID distribution status: In Commercial Distribution

MRI safety: MR Conditional

Other devices from Additive Implants, Inc.

SureMAX 1

Class II
SureMAX-X 1

Class I
SureMAX-SA 1

Class II
SureMAX 1

Class II
SureMAX 1

Class I
SureMAX 1

Class I

See all devices from Additive Implants, Inc. →

Properties

Supplied sterile
Single use
Implantable
Prescription use
Lot / batch number
Expiration date
Manufacturing date

Other properties (8)

Sterilise before use: No
Contains latex: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Premarket exempt: No
Serial number: No