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PYRAMESH™ Implant System

by Medtronic Sofamor Danek USA, Inc.

510(k) K183197

PYRAMESH™ Implant System is a Class II device made by Medtronic Sofamor Danek USA, Inc., cleared under FDA 510(k) K183197 on 4 Apr 2019, active as of 25 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 25 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK183197 Date4 Apr 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  • Withdrawn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
MQP
Device class
Class II
Regulation
21 CFR Part 888.3060
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 K183197

146 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 K183197
UDI-DISize and differences
PYRAMESH® C Titanium Mesh 9050716
MEDTRONIC SOFAMOR DANEK, INC.
905071600681490484268 —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 9050725
MEDTRONIC SOFAMOR DANEK, INC.
905072500681490484299 —On the market
Pyramesh® Implant System 905-103
MEDTRONIC SOFAMOR DANEK, INC.
905-10300673978080574
Length 30.0 mm; Outer Diameter 10.0 mm
On the market
PYRAMESH® Implant System 905-107
MEDTRONIC SOFAMOR DANEK, INC.
905-10700763000855284 —On the market
Pyramesh® Implant System 905-107
MEDTRONIC SOFAMOR DANEK, INC.
905-10700673978080581
Outer Diameter 10.0 mm; Length 70.0 mm
On the market
Pyramesh® Implant System 905-108
MEDTRONIC SOFAMOR DANEK, INC.
905-10800673978080598
Length 8.0 mm; Outer Diameter 10.0 mm
On the market
Pyramesh® Implant System 905-110
MEDTRONIC SOFAMOR DANEK, INC.
905-11000673978080604
Length 10.0 mm; Outer Diameter 10.0 mm
On the market
PYRAMESH® Implant System 905-110
MEDTRONIC SOFAMOR DANEK, INC.
905-11000763000855307 —On the market
Pyramesh® Implant System 905-112
MEDTRONIC SOFAMOR DANEK, INC.
905-11200673978080611
Outer Diameter 10.0 mm; Length 12.0 mm
On the market
Pyramesh® Implant System 905-115
MEDTRONIC SOFAMOR DANEK, INC.
905-11500673978080628
Outer Diameter 10.0 mm; Length 15.0 mm
On the market
Pyramesh® Implant System 905-139
MEDTRONIC SOFAMOR DANEK, INC.
905-13900673978080666
Outer Diameter 13.0 mm; Length 9.0 mm
On the market
Pyramesh® Implant System 905-299
MEDTRONIC SOFAMOR DANEK, INC.
905-29900763000855444 —On the market
Pyramesh® Implant System 905-308
MEDTRONIC SOFAMOR DANEK, INC.
905-30800763000855451 —On the market
Pyramesh® Implant System 905-310
MEDTRONIC SOFAMOR DANEK, INC.
905-31000673978080826
Length 10.0 mm; Outer Diameter 13.0 mm
On the market
Pyramesh® Implant System 905-311
MEDTRONIC SOFAMOR DANEK, INC.
905-31100673978080833
Length 11.0 mm; Outer Diameter 13.0 mm
On the market
PYRAMESH® Implant System 905-320
MEDTRONIC SOFAMOR DANEK, INC.
905-32000763000856397 —On the market
Pyramesh® Implant System 905-399
MEDTRONIC SOFAMOR DANEK, INC.
905-39900673978080871 —On the market
Pyramesh® Implant System 905-409
MEDTRONIC SOFAMOR DANEK, INC.
905-40900763000856458 —On the market
Pyramesh® Implant System 905-409
MEDTRONIC SOFAMOR DANEK, INC.
905-40900673978080925 —On the market
Pyramesh® Implant System 905-411
MEDTRONIC SOFAMOR DANEK, INC.
905-41100763000856465 —On the market
Pyramesh® Implant System 905-412
MEDTRONIC SOFAMOR DANEK, INC.
905-41200673978080949 —On the market
Pyramesh® Implant System 905-412
MEDTRONIC SOFAMOR DANEK, INC.
905-41200763000856472 —On the market
Pyramesh® Implant System 905-509
MEDTRONIC SOFAMOR DANEK, INC.
905-50900763000856519 —On the market
PYRAMESH® Implant System 905-515
MEDTRONIC SOFAMOR DANEK, INC.
905-51500763000856540 —On the market
Pyramesh® Implant System 905-520
MEDTRONIC SOFAMOR DANEK, INC.
905-52000763000856557 —On the market
Pyramesh® Implant System 905-611
MEDTRONIC SOFAMOR DANEK, INC.
905-61100673978081083
Outer Diameter 16.0 mm; Length 11.0 mm
On the market
Pyramesh® Implant System 905-611
MEDTRONIC SOFAMOR DANEK, INC.
905-61100763000856588 —On the market
Pyramesh® Implant System 905-901
MEDTRONIC SOFAMOR DANEK, INC.
905-90100673978081281
Outer Diameter 13.0 mm; Length 130.0 mm
On the market
PYRAMESH® Implant System 9050012
MEDTRONIC SOFAMOR DANEK, INC.
905001200763000855925 —On the market
PYRAMESH® Implant System 9050012
MEDTRONIC SOFAMOR DANEK, INC.
905001200681490844345 —On the market
PYRAMESH® Implant System 9050014
MEDTRONIC SOFAMOR DANEK, INC.
905001400681490844352 —On the market
PYRAMESH® Implant System 9050018
MEDTRONIC SOFAMOR DANEK, INC.
905001800763000855956 —On the market
PYRAMESH® Implant System 9050414
MEDTRONIC SOFAMOR DANEK, INC.
905041400763000855512 —On the market
PYRAMESH® Implant System 9050513
MEDTRONIC SOFAMOR DANEK, INC.
905051300763000855536 —On the market
PYRAMESH® Implant System 9050823
MEDTRONIC SOFAMOR DANEK, INC.
905082300681490844390 —On the market
PYRAMESH® Implant System 9051011
MEDTRONIC SOFAMOR DANEK, INC.
905101100763000855611 —On the market
PYRAMESH® Implant System 9051013
MEDTRONIC SOFAMOR DANEK, INC.
905101300681490484459 —On the market
PYRAMESH® Implant System 9051050
MEDTRONIC SOFAMOR DANEK, INC.
905105000681490484473 —On the market
PYRAMESH® Implant System 9051314
MEDTRONIC SOFAMOR DANEK, INC.
905131400763000855659 —On the market
PYRAMESH® Implant System 9051423
MEDTRONIC SOFAMOR DANEK, INC.
905142300681490844420 —On the market
PYRAMESH® Implant System 9051915
MEDTRONIC SOFAMOR DANEK, INC.
905191500681490484602 —On the market
PYRAMESH® Implant System 9051918
MEDTRONIC SOFAMOR DANEK, INC.
905191800681490484619 —On the market
PYRAMESH® Implant System 9052205
MEDTRONIC SOFAMOR DANEK, INC.
905220500763000855772 —On the market
PYRAMESH® Implant System 9052230
MEDTRONIC SOFAMOR DANEK, INC.
905223000681490484664 —On the market
PYRAMESH® Implant System 9052318
MEDTRONIC SOFAMOR DANEK, INC.
905231800681490484718 —On the market
PYRAMESH® Implant System 9052518
MEDTRONIC SOFAMOR DANEK, INC.
905251800681490484732 —On the market
PYRAMESH® Implant System 9052815
MEDTRONIC SOFAMOR DANEK, INC.
905281500681490484749 —On the market
PYRAMESH® Implant System 9052830
MEDTRONIC SOFAMOR DANEK, INC.
905283000681490484756 —On the market

Similar devices

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