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Cervical Spacer

by Additive Implants, LLC

510(k) K182477

Cervical Spacer is a Class II device made by Additive Implants, LLC, cleared under FDA 510(k) K182477 on 28 Jan 2019, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK182477 Date28 Jan 2019ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
ODP
Device class
Class II
Regulation
21 CFR Part 888.3080
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K182477

229 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K182477
UDI-DISize and differences
SureMAX 1
Additive Implants, Inc.
100817662023519
Angle 7 deg; Depth 12 mm; Width 14 mm; Height 5 mm
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662023816
Height 11 mm; Width 14 mm; Depth 12 mm; Angle 14 deg
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662024011
Angle 0 deg; Depth 12 mm; Width 14 mm; Height 7 mm
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662020143
Height 14 mm; Width 16 mm; Depth 11 mm; Angle 7 deg
Prescription: yes; Single use: yes
On the market
SureMAX 1
Additive Implants, Inc.
100817662024592
Length 211.3 mm; Outer Diameter 10 mm
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662020051
Angle 7 deg; Depth 12 mm; Width 14 mm; Height 10 mm
Prescription: yes; Single use: yes
On the market
SureMAX 1
Additive Implants, Inc.
100817662020112
Angle 7 deg; Depth 8 mm; Width 16 mm; Height 14 mm
Prescription: yes; Single use: yes
On the market
SureMAX 1
Additive Implants, Inc.
100817662023045
Angle 7 deg; Depth 12 mm; Width 14 mm; Height 7 mm
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662024479
Height 4.5 mm; Width 18 mm; Depth 15 mm; Angle 7 deg
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662020396
Angle 14 deg; Depth 12 mm; Width 16 mm; Height 14 mm
Prescription: yes; Single use: yes
On the market
SureMAX 1
Additive Implants, Inc.
100817662020464
Height 15 mm; Width 18 mm; Depth 11 mm; Angle 14 deg
Prescription: yes; Single use: yes
On the market
SureMAX 1
Additive Implants, Inc.
100817662020556
Angle 0 deg; Depth 12 mm; Width 14 mm; Height 12 mm
Prescription: yes; Single use: yes
On the market
SureMAX 1
Additive Implants, Inc.
100817662024325
Angle 7 deg; Depth 12 mm; Width 14 mm; Height 11.5 mm
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662023687
Angle 7 deg; Depth 15 mm; Width 18 mm; Height 6 mm
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662020662
Height 15 mm; Width 18 mm; Depth 7 mm; Angle 0 deg
Prescription: yes; Single use: yes
On the market
SureMAX 1
Additive Implants, Inc.
100817662024431
Height 11.5 mm; Width 16 mm; Depth 14 mm; Angle 7 deg
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662023182
Angle 7 deg; Depth 15 mm; Width 18 mm; Height 5 mm
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662024189
Angle 0 deg; Depth 15 mm; Width 18 mm; Height 8 mm
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662024394
Height 7.5 mm; Width 16 mm; Depth 14 mm; Angle 7 deg
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662023793
Height 9 mm; Width 14 mm; Depth 12 mm; Angle 14 deg
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662021638
Height 2.53 in; Width 9.72 in; Length 20.85 in
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662023168
Angle 7 deg; Depth 14 mm; Width 16 mm; Height 11 mm
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662020082
Height 14 mm; Width 16 mm; Depth 5 mm; Angle 7 deg
Prescription: yes; Single use: yes
On the market
SureMAX 1
Additive Implants, Inc.
100817662020716
Angle 0 deg; Depth 12 mm; Width 18 mm; Height 15 mm
Prescription: yes; Single use: yes
On the market
SureMAX 1
Additive Implants, Inc.
100817662024202
Angle 0 deg; Depth 15 mm; Width 18 mm; Height 10 mm
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662023069
Angle 7 deg; Depth 12 mm; Width 14 mm; Height 9 mm
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662021706
Length 21.13 in; Width 10 in; Height 3.28 in
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662020433
Angle 14 deg; Depth 8 mm; Width 18 mm; Height 15 mm
Prescription: yes; Single use: yes
On the market
SureMAX 1
Additive Implants, Inc.
100817662023083
Angle 7 deg; Depth 12 mm; Width 14 mm; Height 11 mm
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662024301
Angle 7 deg; Depth 12 mm; Width 14 mm; Height 9.5 mm
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662024141
Angle 0 deg; Depth 14 mm; Width 16 mm; Height 12 mm
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662023236
Height 10 mm; Width 18 mm; Depth 15 mm; Angle 7 deg
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662024295
Height 8.5 mm; Width 14 mm; Depth 12 mm; Angle 7 deg
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662020365
Height 14 mm; Width 16 mm; Depth 9 mm; Angle 14 deg
Prescription: yes; Single use: yes
On the market
SureMAX 1
Additive Implants, Inc.
100817662023847
Height 6 mm; Width 14 mm; Depth 12 mm; Angle 14 deg
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662020600
Height 14 mm; Width 16 mm; Depth 9 mm; Angle 0 deg
Prescription: yes; Single use: yes
On the market
SureMAX 1
Additive Implants, Inc.
100817662020167
Height 15 mm; Width 18 mm; Depth 5 mm; Angle 7 deg
Prescription: yes; Single use: yes
On the market
SureMAX 1
Additive Implants, Inc.
100817662024172
Angle 0 deg; Depth 15 mm; Width 18 mm; Height 7 mm
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662024486
Angle 7 deg; Depth 15 mm; Width 18 mm; Height 5.5 mm
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662020068
Angle 7 deg; Depth 12 mm; Width 14 mm; Height 11 mm
Prescription: yes; Single use: yes
On the market
SureMAX 1
Additive Implants, Inc.
100817662023786
Height 8 mm; Width 14 mm; Depth 12 mm; Angle 14 deg
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662023762
Height 6 mm; Width 14 mm; Depth 12 mm; Angle 14 deg
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662020594
Angle 0 deg; Depth 8 mm; Width 16 mm; Height 14 mm
Prescription: yes; Single use: yes
On the market
SureMAX 1
Additive Implants, Inc.
100817662023533
Angle 7 deg; Depth 12 mm; Width 14 mm; Height 7 mm
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662023892
Angle 14 deg; Depth 14 mm; Width 16 mm; Height 11 mm
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662023854
Angle 14 deg; Depth 14 mm; Width 16 mm; Height 7 mm
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662023809
Height 10 mm; Width 14 mm; Depth 12 mm; Angle 14 deg
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662020648
Height 15 mm; Width 18 mm; Depth 5 mm; Angle 0 deg
Prescription: yes; Single use: yes
On the market
SureMAX 1
Additive Implants, Inc.
100817662024028
Angle 0 deg; Depth 12 mm; Width 14 mm; Height 8 mm
Prescription: no; Single use: no
On the market
SureMAX 1
Additive Implants, Inc.
100817662024363
Angle 7 deg; Depth 14 mm; Width 16 mm; Height 4.5 mm
Prescription: no; Single use: no
On the market

Similar devices

Other devices filed under FDA product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical).

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. →