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Endoskeleton TAS Plate

by Titan Spine, Inc.

510(k) K192054

Endoskeleton TAS Plate is a Class II device made by Titan Spine, Inc., cleared under FDA 510(k) K192054 on 29 Aug 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 · Special NumberK192054 Date29 Aug 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  • Withdrawn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
OVD
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

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

Devices cleared under K192054

10 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 K192054
UDI-DISize and differences
ENDOSKELETON® TAS 2300-1303
MEDTRONIC SOFAMOR DANEK, INC.
2300-130300191375039983
Length 15 in
On the market
ENDOSKELETON® TAS 2300-1304
MEDTRONIC SOFAMOR DANEK, INC.
2300-130400191375028963
Length 15 in
On the market
ENDOSKELETON® TAS 2300-1305
MEDTRONIC SOFAMOR DANEK, INC.
2300-130500191375028987
Length 15 in
On the market
ENDOSKELETON® TAS 2300-1310
MEDTRONIC SOFAMOR DANEK, INC.
2300-131000191375028222
Length 15 in
On the market
ENDOSKELETON® TAS 2300-1311
MEDTRONIC SOFAMOR DANEK, INC.
2300-131100191375028239
Length 15 in
On the market
ENDOSKELETON® TAS 2300-1318
MEDTRONIC SOFAMOR DANEK, INC.
2300-131800191375040101
Length 15 in
On the market
ENDOSKELETON® TAS 2300-1319
MEDTRONIC SOFAMOR DANEK, INC.
2300-131900191375040118
Length 15 in
On the market
ENDOSKELETON® TAS 2300-1320
MEDTRONIC SOFAMOR DANEK, INC.
2300-132000191375040125
Length 15 in
On the market
ENDOSKELETON® TAS 2301-0005
Titan Spine, Inc.
2301-0005 / 2301-000500191375050438
Length 12 in
No longer on the market
ENDOSKELETON® TAS 2301-0006
Titan Spine, Inc.
2301-0006 / 2301-000600191375050445
Length 12 in
No longer on the market

Similar devices

Other devices filed under FDA product code OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar).

Other devices from Titan Spine, Inc.

See all devices from Titan Spine, Inc. →