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Perimeter C Spinal System

by Medtronic Sofamor Danek USA, Inc. 2 variants

510(k) K132584

Perimeter C Spinal System is a Class II device made by Medtronic Sofamor Danek USA, Inc., cleared under FDA 510(k) K132584 on 4 Dec 2013, 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 NumberK132584 Date4 Dec 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  • Withdrawn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
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 K132584

16 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 K132584
UDI-DISize and differences
PERIMETER® C Spinal System X0312070
MEDTRONIC SOFAMOR DANEK, INC.
X031207000643169200593
Width 13.0 mm; Length 12.0 mm; Height 5.0 mm
On the market
PERIMETER® C Spinal System X0312071
MEDTRONIC SOFAMOR DANEK, INC.
X031207100643169200609
Width 13.0 mm; Height 6.0 mm; Length 12.0 mm
On the market
PERIMETER® C Spinal System X0312072
MEDTRONIC SOFAMOR DANEK, INC.
X031207200643169200616
Length 12.0 mm; Height 7.0 mm; Width 13.0 mm
On the market
PERIMETER® C Spinal System X0312073
MEDTRONIC SOFAMOR DANEK, INC.
X031207300643169200623
Height 8.0 mm; Width 13.0 mm; Length 12.0 mm
On the market
PERIMETER® C Spinal System X0312074
MEDTRONIC SOFAMOR DANEK, INC.
X031207400643169200630
Width 13.0 mm; Height 9.0 mm; Length 12.0 mm
On the market
PERIMETER® C Spinal System X0312075
MEDTRONIC SOFAMOR DANEK, INC.
X031207500643169200647
Height 10.0 mm; Width 13.0 mm; Length 12.0 mm
On the market
PERIMETER® C Spinal System X0312076
MEDTRONIC SOFAMOR DANEK, INC.
X031207600643169200654
Length 12.0 mm; Width 13.0 mm; Height 11.0 mm
On the market
PERIMETER® C Spinal System X0312077
MEDTRONIC SOFAMOR DANEK, INC.
X031207700643169200661
Width 13.0 mm; Length 12.0 mm; Height 12.0 mm
On the market
PERIMETER® C Spinal System X0312078
MEDTRONIC SOFAMOR DANEK, INC.
X031207800643169200678
Height 5.0 mm; Width 15.0 mm; Length 13.0 mm
On the market
PERIMETER® C Spinal System X0312079
MEDTRONIC SOFAMOR DANEK, INC.
X031207900643169200685
Height 6.0 mm; Width 15.0 mm; Length 13.0 mm
On the market
PERIMETER® C Spinal System X0312080
MEDTRONIC SOFAMOR DANEK, INC.
X031208000643169200692
Length 13.0 mm; Height 7.0 mm; Width 15.0 mm
On the market
PERIMETER® C Spinal System X0312081
MEDTRONIC SOFAMOR DANEK, INC.
X031208100643169200708
Height 8.0 mm; Length 13.0 mm; Width 15.0 mm
On the market
PERIMETER® C Spinal System X0312082
MEDTRONIC SOFAMOR DANEK, INC.
X031208200643169200715
Width 15.0 mm; Height 9.0 mm; Length 13.0 mm
On the market
PERIMETER® C Spinal System X0312083
MEDTRONIC SOFAMOR DANEK, INC.
X031208300643169200722
Length 13.0 mm; Height 10.0 mm; Width 15.0 mm
On the market
PERIMETER® C Spinal System X0312084
MEDTRONIC SOFAMOR DANEK, INC.
X031208400643169200739
Length 13.0 mm; Width 15.0 mm; Height 11.0 mm
On the market
PERIMETER® C Spinal System X0312085
MEDTRONIC SOFAMOR DANEK, INC.
X031208500643169200746
Length 13.0 mm; Width 15.0 mm; Height 12.0 mm
On the market

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