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Spinal Mesh System

by Medtronic Sofamor Danek, Inc.

510(k) K011406

Spinal Mesh System is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K011406 on 27 Dec 2001, 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 NumberK011406 Date27 Dec 2001ClearedStatusActive

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  • Withdrawn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
MQP
Device class
Class II
Regulation
21 CFR Part 888.3060
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

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

Cited by

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

Devices cleared under K011406

92 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 K011406
UDI-DISize and differences
CD HORIZON® Spinal System X0507157
MEDTRONIC SOFAMOR DANEK, INC.
X050715700613994351395
Height 10.0 mm; Length 25.0 mm
On the market
CD HORIZON® Spinal System X0507159
MEDTRONIC SOFAMOR DANEK, INC.
X050715900613994351364
Length 25.0 mm; Height 10.0 mm
On the market
CD HORIZON® Spinal System X0507160
MEDTRONIC SOFAMOR DANEK, INC.
X050716000613994351371
Length 25.0 mm; Height 10.0 mm
On the market
PYRAMESH® C Titanium Mesh 905-403
MEDTRONIC SOFAMOR DANEK, INC.
905-40300763000856427 —On the market
PYRAMESH® C Titanium Mesh 9050450
MEDTRONIC SOFAMOR DANEK, INC.
905045000681490484213 —On the market
PYRAMESH® C Titanium Mesh 9050713
MEDTRONIC SOFAMOR DANEK, INC.
905071300681490484251 —On the market
PYRAMESH® C Titanium Mesh 9050716
MEDTRONIC SOFAMOR DANEK, INC.
905071600681490484268 —On the market
PYRAMESH® C Titanium Mesh 9050716
MEDTRONIC SOFAMOR DANEK, INC.
905071600763000855567 —On the market
PYRAMESH® C Titanium Mesh 9050719
MEDTRONIC SOFAMOR DANEK, INC.
905071900763000855574 —On the market
PYRAMESH® C Titanium Mesh 9050722
MEDTRONIC SOFAMOR DANEK, INC.
905072200763000855581 —On the market
PYRAMESH® C Titanium Mesh 9050722
MEDTRONIC SOFAMOR DANEK, INC.
905072200681490484282 —On the market
PYRAMESH® C Titanium Mesh 9050725
MEDTRONIC SOFAMOR DANEK, INC.
905072500681490484299 —On the market
PYRAMESH® C Titanium Mesh 9051690
MEDTRONIC SOFAMOR DANEK, INC.
905169000763000855680 —On the market
PYRAMESH® C Titanium Mesh 9051690
MEDTRONIC SOFAMOR DANEK, INC.
905169000681490484527 —On the market
PYRAMESH® C Titanium Mesh 9051730
MEDTRONIC SOFAMOR DANEK, INC.
905173000681490484565 —On the market
PYRAMESH® C Titanium Mesh 9051750
MEDTRONIC SOFAMOR DANEK, INC.
905175000763000855727 —On the market
PYRAMESH® C Titanium Mesh 9051750
MEDTRONIC SOFAMOR DANEK, INC.
905175000681490484572 —On the market
PYRAMESH® C Titanium Mesh 9051770
MEDTRONIC SOFAMOR DANEK, INC.
905177000681490484589 —On the market
PYRAMESH® C Titanium Mesh 9051770
MEDTRONIC SOFAMOR DANEK, INC.
905177000763000855734 —On the market
PYRAMESH® C Titanium Mesh 9051790
MEDTRONIC SOFAMOR DANEK, INC.
905179000763000855741 —On the market
PYRAMESH® C Titanium Mesh 9051790
MEDTRONIC SOFAMOR DANEK, INC.
905179000681490484596 —On the market
PYRAMESH® C Titanium Mesh 9052250
MEDTRONIC SOFAMOR DANEK, INC.
905225000681490484671 —On the market
PYRAMESH® C Titanium Mesh 9052250
MEDTRONIC SOFAMOR DANEK, INC.
905225000763000855819 —On the market
PYRAMESH® C Titanium Mesh 9052270
MEDTRONIC SOFAMOR DANEK, INC.
905227000763000855826 —On the market
PYRAMESH® C Titanium Mesh 9052290
MEDTRONIC SOFAMOR DANEK, INC.
905229000681490484695 —On the market
PYRAMESH® C Titanium Mesh 9052850
MEDTRONIC SOFAMOR DANEK, INC.
905285000681490484763 —On the market
PYRAMESH® C Titanium Mesh 9052870
MEDTRONIC SOFAMOR DANEK, INC.
905287000763000855901 —On the market
PYRAMESH® C Titanium Mesh 9052890
MEDTRONIC SOFAMOR DANEK, INC.
905289000763000855918 —On the market
PYRAMESH® C Titanium Mesh 9052890
MEDTRONIC SOFAMOR DANEK, INC.
905289000681490484787 —On the market
PYRAMESH® C Titanium Mesh X0210024
MEDTRONIC SOFAMOR DANEK, INC.
X021002400613994774675
Length 17.0 mm; Outer Diameter 13.0 mm
No longer on the market
PYRAMESH® C Titanium Mesh X050291
MEDTRONIC SOFAMOR DANEK, INC.
X05029100885074471570 —On the market
PYRAMESH® C Titanium Mesh X050293
MEDTRONIC SOFAMOR DANEK, INC.
X05029300885074471594 —On the market
PYRAMESH® C Titanium Mesh X050294
MEDTRONIC SOFAMOR DANEK, INC.
X05029400885074471617 —On the market
PYRAMESH® C Titanium Mesh X050296
MEDTRONIC SOFAMOR DANEK, INC.
X05029600885074471648 —On the market
PYRAMESH® C Titanium Mesh X1009460
MEDTRONIC SOFAMOR DANEK, INC.
X100946000613994738684
Length 17.0 mm
On the market
PYRAMESH® C Titanium Mesh XIB0801-006
MEDTRONIC SOFAMOR DANEK, INC.
XIB0801-00600721902264382 —No longer on the market
PYRAMESH® C Titanium Mesh XIB0801-007
MEDTRONIC SOFAMOR DANEK, INC.
XIB0801-00700721902264368 —No longer on the market
PYRAMESH® C Titanium Mesh XIB0801-011
MEDTRONIC SOFAMOR DANEK, INC.
XIB0801-01100721902264481 —On the market
PYRAMESH® C Titanium Mesh XIB1101-009
MEDTRONIC SOFAMOR DANEK, INC.
XIB1101-00900721902362521 —On the market
Pyramesh® Implant System 905-133
MEDTRONIC SOFAMOR DANEK, INC.
905-13300673978080642
Outer Diameter 13.0 mm; Length 30.0 mm
On the market
PYRAMESH® Implant System 905-166
MEDTRONIC SOFAMOR DANEK, INC.
905-16600763000855383 —On the market
Pyramesh® Implant System 905-166
MEDTRONIC SOFAMOR DANEK, INC.
905-16600673978080697
Length 60.0 mm; Outer Diameter 16.0 mm
On the market
PYRAMESH® Implant System 905-194
MEDTRONIC SOFAMOR DANEK, INC.
905-19400763000855390 —On the market
PYRAMESH® Implant System 905-251
MEDTRONIC SOFAMOR DANEK, INC.
905-25100763000855413 —On the market
Pyramesh® Implant System 905-251
MEDTRONIC SOFAMOR DANEK, INC.
905-25100673978080758
Outer Diameter 25.0 mm; Length 100.0 mm
On the market
Pyramesh® Implant System 905-256
MEDTRONIC SOFAMOR DANEK, INC.
905-25600673978080772
Outer Diameter 25.0 mm; Length 60.0 mm
On the market
Pyramesh® Implant System 905-299
MEDTRONIC SOFAMOR DANEK, INC.
905-29900763000855444 —On the market
Pyramesh® Implant System 905-399
MEDTRONIC SOFAMOR DANEK, INC.
905-39900673978080871 —On the market
Pyramesh® Implant System 905-399
MEDTRONIC SOFAMOR DANEK, INC.
905-39900763000856403 —On the market
Pyramesh® Implant System 905-403
MEDTRONIC SOFAMOR DANEK, INC.
905-40300673978080895 —On the market

Similar devices

Other devices filed under FDA product code MQP (Spinal Vertebral Body Replacement Device).

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