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Plateau Spacer System Titanium

by Life Spine, Inc.

510(k) K130630

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 · Special NumberK130630 Date13 Jun 2013ClearedStatusActive

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  • Withdrawn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
MAX
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

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Plateau Spacer System Titanium is an interbody spinal fusion device designed for posterior or transforaminal surgical approaches. Constructed from titanium, it is intended for use in procedures such as PLIF (Posterior Lumbar Interbody Fusion) and TLIF (Transforaminal Lumbar Interbody Fusion) to restore spinal alignment and promote bone fusion through precise interbody placement.

This system is supplied as a reusable surgical implant and is regulated under FDA 510(k) clearance (K130630) as a Special submission within the Orthopedic advisory committee category. Available in multiple sizes and configurations, it is intended for use in spinal procedures where titanium’s biocompatibility and structural integrity are advantageous. Sterility and packaging details are not specified in the regulatory data.

Devices cleared under K130630

87 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 K130630
UDI-DISize and differences
10mm x 24mm x 10mm Titanium PLATEAU Interbody, 7°, Straight, Bulleted 54-1024-710T
Life Spine, Inc.
54-1024-710T00190837018894
Prescription: yes; Single use: yes
On the market
10mm x 24mm x 12mm Titanium PLATEAU Interbody, 7°, Straight, Bulleted 54-1024-712T
Life Spine, Inc.
54-1024-712T00190837018917
Prescription: yes; Single use: yes
On the market
10mm x 24mm x 14mm Titanium PLATEAU Interbody, 7°, Straight, Bulleted 54-1024-714T
Life Spine, Inc.
54-1024-714T00190837018931
Prescription: yes; Single use: yes
On the market
10mm x 24mm x 15mm Titanium PLATEAU Interbody, 7°, Straight, Bulleted 54-1024-715T
Life Spine, Inc.
54-1024-715T00190837018948
Prescription: yes; Single use: yes
On the market
10mm x 24mm x 16mm Titanium PLATEAU Interbody, 0°, Straight, Bulleted 52-1024-16T
Life Spine, Inc.
52-1024-16T00190837018610
Prescription: yes; Single use: yes
On the market
10mm x 24mm x 16mm Titanium PLATEAU Interbody, 7°, Straight, Bulleted 54-1024-716T
Life Spine, Inc.
54-1024-716T00190837018955
Prescription: yes; Single use: yes
On the market
10mm x 24mm x 8mm Titanium PLATEAU Interbody, 0°, Straight, Bulleted 52-1024-08T
Life Spine, Inc.
52-1024-08T00190837018535
Prescription: yes; Single use: yes
On the market
10mm x 24mm x 9mm Titanium PLATEAU Interbody, 0°, Straight, Bulleted 52-1024-09T
Life Spine, Inc.
52-1024-09T00190837018542
Prescription: yes; Single use: yes
On the market
10mm x 24mm x 9mm Titanium PLATEAU Interbody, 7°, Straight, Bulleted 54-1024-709T
Life Spine, Inc.
54-1024-709T00190837018887
Prescription: yes; Single use: yes
On the market
10mm x 28mm x 11mm Titanium PLATEAU Interbody, 0°, Straight, Bulleted 52-1028-11T
Life Spine, Inc.
52-1028-11T00190837018658
Prescription: no; Single use: yes
On the market
10mm x 28mm x 12mm Titanium PLATEAU Interbody, 0°, Straight, Bulleted 52-1028-12T
Life Spine, Inc.
52-1028-12T00190837018665
Prescription: yes; Single use: yes
On the market
10mm x 28mm x 13mm Titanium PLATEAU Interbody, 0°, Straight, Bulleted 52-1028-13T
Life Spine, Inc.
52-1028-13T00190837018672
Prescription: yes; Single use: yes
On the market
10mm x 28mm x 14mm Titanium PLATEAU Interbody, 0°, Straight, Bulleted 52-1028-14T
Life Spine, Inc.
52-1028-14T00190837018689
Prescription: yes; Single use: yes
On the market
10mm x 28mm x 15mm Titanium PLATEAU Interbody, 0°, Straight, Bulleted 52-1028-15T
Life Spine, Inc.
52-1028-15T00190837018696
Prescription: yes; Single use: yes
On the market
10mm x 28mm x 8mm Titanium PLATEAU Interbody, 0°, Straight, Bulleted 52-1028-08T
Life Spine, Inc.
52-1028-08T00190837018627
Prescription: yes; Single use: yes
On the market
10mm x 28mm x 9mm Titanium PLATEAU Interbody, 0°, Straight, Bulleted 52-1028-09T
Life Spine, Inc.
52-1028-09T00190837018634
Prescription: yes; Single use: yes
On the market
Plateau 2018-0017
Life Spine, Inc.
2018-0017 / 2018-001700190837032289
Prescription: yes; Single use: no
On the market
Plateau Ti 129-562
Life Spine, Inc.
129-562 / 129-56200190837083977
Prescription: yes; Single use: no
On the market
Plateau Ti Curved 113-783
Life Spine, Inc.
113-783 / 113-78300190837061074
Prescription: yes; Single use: no
On the market
Plateau Ti Curved 114-100
Life Spine, Inc.
114-100 / 114-10000190837061081
Prescription: yes; Single use: no
On the market
Plateau Ti Curved 114-202-14
Life Spine, Inc.
114-202-14 / 114-202-1400190837061104
Prescription: yes; Single use: no
On the market
Plateau Ti Curved 129-550
Life Spine, Inc.
129-550 / 129-55000190837061166
Prescription: yes; Single use: no
On the market
Plateau Ti Curved 129-568
Life Spine, Inc.
129-568 / 129-56800190837061180
Prescription: yes; Single use: no
On the market
Plateau Ti Curved 129-596
Life Spine, Inc.
129-596 / 129-59600190837061210
Prescription: yes; Single use: no
On the market
Plateau Ti Curved 55-1027-08T
Life Spine, Inc.
55-1027-08T00190837018795
Prescription: yes; Single use: yes
On the market
Plateau Ti Curved 55-1027-09T
Life Spine, Inc.
55-1027-09T00190837018801
Prescription: yes; Single use: yes
On the market
Plateau Ti Curved 55-1027-10T
Life Spine, Inc.
55-1027-10T00190837018818
Prescription: yes; Single use: yes
On the market
Plateau Ti Curved 55-1027-12T
Life Spine, Inc.
55-1027-12T00190837018832
Prescription: yes; Single use: yes
On the market
Plateau Ti Curved 55-1027-16T
Life Spine, Inc.
55-1027-16T00190837018870
Prescription: yes; Single use: yes
On the market
Plateau Ti Curved 55-1032-06T
Life Spine, Inc.
55-1032-06T / 55-1032-06T00190837061227
Prescription: yes; Single use: yes
On the market
Plateau Ti Curved 55-1032-08T
Life Spine, Inc.
55-1032-08T / 55-1032-08T00190837061241
Prescription: yes; Single use: yes
On the market
Plateau Ti Curved 55-1032-09T
Life Spine, Inc.
55-1032-09T / 55-1032-09T00190837061258
Prescription: yes; Single use: yes
On the market
Plateau Ti Curved 55-1032-11T
Life Spine, Inc.
55-1032-11T / 55-1032-11T00190837061272
Prescription: yes; Single use: yes
On the market
Plateau Ti Curved 55-1032-12T
Life Spine, Inc.
55-1032-12T / 55-1032-12T00190837061289
Prescription: yes; Single use: yes
On the market
Plateau Ti Curved 55-1032-13T
Life Spine, Inc.
55-1032-13T / 55-1032-13T00190837061296
Prescription: yes; Single use: yes
On the market
Plateau Ti Curved 55-1032-15T
Life Spine, Inc.
55-1032-15T / 55-1032-15T00190837061319
Prescription: yes; Single use: yes
On the market
Plateau Ti Curved Instruments 2019-0066
Life Spine, Inc.
2019-0066 / 2019-006600190837077440
Prescription: yes; Single use: no
On the market
Plateau-Z 10mm x 24mm x 10mm, 0°, Titanium 43-1024-10T
Life Spine, Inc.
43-1024-10T00190837018399
Prescription: yes; Single use: yes
On the market
Plateau-Z 10mm x 24mm x 11mm, 0°, Titanium 43-1024-11T
Life Spine, Inc.
43-1024-11T00190837018405
Prescription: yes; Single use: yes
On the market
Plateau-Z 10mm x 24mm x 13mm, 0°, Titanium 43-1024-13T
Life Spine, Inc.
43-1024-13T00190837018429
Prescription: yes; Single use: yes
On the market
Plateau-Z 10mm x 24mm x 14mm, 0°, Titanium 43-1024-14T
Life Spine, Inc.
43-1024-14T00190837018436
Prescription: yes; Single use: yes
On the market
Plateau-Z 10mm x 24mm x 16mm, 0°, Titanium 43-1024-16T
Life Spine, Inc.
43-1024-16T00190837018450
Prescription: yes; Single use: yes
On the market
Plateau-Z 10mm x 28mm x 10mm, 0°, Titanium 43-1028-10T
Life Spine, Inc.
43-1028-10T00190837018320
Prescription: yes; Single use: yes
On the market
Plateau-Z 10mm x 28mm x 11mm, 0°, Titanium 43-1028-11T
Life Spine, Inc.
43-1028-11T00190837018337
Prescription: yes; Single use: yes
On the market
Plateau-Z 10mm x 30mm x 10mm, 0°, Titanium 43-1030-10T
Life Spine, Inc.
43-1030-10T00190837018467
Prescription: yes; Single use: yes
On the market
Plateau-Z 10mm x 30mm x 11mm, 0°, Titanium 43-1030-11T
Life Spine, Inc.
43-1030-11T00190837018474
Prescription: yes; Single use: yes
On the market
Plateau-Z 10mm x 30mm x 13mm, 0°, Titanium 43-1030-13T
Life Spine, Inc.
43-1030-13T00190837018498
Prescription: yes; Single use: yes
On the market
Plateau-Z 10mm x 30mm x 14mm, 0°, Titanium 43-1030-14T
Life Spine, Inc.
43-1030-14T00190837018504
Prescription: yes; Single use: yes
On the market
Plateau-Z 10mm x 30mm x 15mm, 0°, Titanium 43-1030-15T
Life Spine, Inc.
43-1030-15T00190837018511
Prescription: yes; Single use: yes
On the market
Plateau-Z 10mm x 30mm x 16mm, 0°, Titanium 43-1030-16T
Life Spine, Inc.
43-1030-16T00190837018528
Prescription: yes; Single use: yes
On the market

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