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SureMAX 1

by Additive Implants, Inc. 84 variants

SureMAX 1 is a Class II device made by Additive Implants, Inc., cleared under FDA 510(k) K182477 on 28 Jan 2019 and listed in FDA GUDID since 19 Feb 2019 (UDI-DI 00817662020112), 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

510(k) K182477

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817662020112 UDI-DI Date19 Feb 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK182477 Date28 Jan 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K182477 decided 28 Jan 2019 Active
  • FDA GUDID UDI-DI 00817662020112 listed 19 Feb 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K182477
  2. Listed FDA GUDID 00817662020112

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SureMAX
Generic name
Metallic spinal interbody fusion cage
Model / reference
1
Primary DI / UDI-DI
00817662020112
510(k) Number
FDA product code
ODP
GMDN term
Metallic spinal interbody fusion cage
Device class
Class II
Regulation number
888.3080
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional
Size
Angle — 7 degree
Depth — 8 Millimeter
Width — 16 Millimeter
Height — 14 Millimeter

Related devices

Category: Metallic spinal interbody fusion cage

Cleared under the same submission (K182477)

and 8 more cleared under K182477

Similar devices in this category

Other devices filed under Metallic spinal interbody fusion cage.

Other devices from Additive Implants, Inc.

  • SureMAX 1

    Class II

  • SureMAX-X 1

    Class I

  • SureMAX-SA 1

    Class II

  • SureMAX 1

    Class II

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, all answered No)