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Erisma-LP

by Clariance

510(k) K120469

Erisma-LP is a Class II device made by Clariance, cleared under FDA 510(k) K120469 on 13 Aug 2012, 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 NumberK120469 Date13 Aug 2012ClearedStatusActive

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  • Withdrawn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
NKB
Device class
Class II
Regulation
21 CFR Part 888.3070
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 K120469

396 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 K120469
UDI-DISize and differences
Erisma®-LP 01720001
Clariance, Inc.
01720001 / 0172000103700780601530
Prescription: yes; Single use: no
On the market
Erisma®-LP 18111090
Clariance, Inc.
18111090 / 1811109003700780604999
Outer Diameter 10.5 mm; Length 90 mm
Prescription: yes; Single use: yes
On the market
Erisma®-LP 18114520
Clariance, Inc.
18114520 / 1811452003700780605019
Outer Diameter 4.5 mm; Length 20 mm
Prescription: yes; Single use: yes
On the market
Erisma®-LP 18115550
Clariance, Inc.
18115550 / 1811555003700780605651
Outer Diameter 5.5 mm; Length 50 mm
Prescription: yes; Single use: yes
On the market
Erisma®-LP 18116535
Clariance, Inc.
18116535 / 1811653503700780605767
Length 35 mm; Outer Diameter 6.5 mm
Prescription: yes; Single use: yes
On the market
Erisma®-LP 18117530
Clariance, Inc.
18117530 / 1811753003700780605927
Length 30 mm; Outer Diameter 7.5 mm
Prescription: yes; Single use: yes
On the market
Erisma®-LP 18118540
Clariance, Inc.
18118540 / 1811854003700780606108
Length 40 mm; Outer Diameter 8.5 mm
Prescription: yes; Single use: yes
On the market
Erisma®-LP 18119530
Clariance, Inc.
18119530 / 1811953003700780606245
Length 30 mm; Outer Diameter 9.5 mm
Prescription: yes; Single use: yes
On the market
Erisma®-LP 18119560
Clariance, Inc.
18119560 / 1811956003700780606399
Length 60 mm; Outer Diameter 9.5 mm
Prescription: yes; Single use: yes
On the market
Erisma®-LP 18119580
Clariance, Inc.
18119580 / 1811958003700780606474
Length 80 mm; Outer Diameter 9.5 mm
Prescription: yes; Single use: yes
On the market
Erisma®-LP 18119590
Clariance, Inc.
18119590 / 1811959003700780606498
Length 90 mm; Outer Diameter 9.5 mm
Prescription: yes; Single use: yes
On the market
Erisma®-LP 18710003
Clariance, Inc.
18710003 / 1871000303700780609109
Prescription: yes; Single use: no
On the market
Erisma®-LP 18710023
Clariance, Inc.
18710023 / 1871002303700780615858
Prescription: yes; Single use: no
On the market
Erisma®-LP 18720003
Clariance, Inc.
18720003 / 1872000303700780609345
Prescription: yes; Single use: no
On the market
Erisma®-LP 18721002
Clariance, Inc.
18721002 / 1872100203700780609406
Prescription: yes; Single use: no
On the market
Erisma®-LP 18721005
Clariance, Inc.
18721005 / 1872100503700780613298
Prescription: yes; Single use: no
On the market
Erisma®-LP 18742005
Clariance, Inc.
18742005 / 1874200503700780609499
Prescription: yes; Single use: no
On the market
Erisma™-LP 18011010
Clariance, Inc.
18011010 / 1801101003700780612451
Length 100 mm; Outer Diameter 10.5 mm
Prescription: yes; Single use: yes
On the market
Erisma™-LP 18015525
Clariance, Inc.
18015525 / 1801552503700780605071
Length 25 mm; Outer Diameter 5.5 mm
Prescription: yes; Single use: yes
On the market
Erisma™-LP 18015530
Clariance, Inc.
18015530 / 1801553003700780605088
Length 30 mm; Outer Diameter 5.5 mm
Prescription: yes; Single use: yes
On the market
Erisma™-LP 18016535
Clariance, Inc.
18016535 / 1801653503700780605156
Length 35 mm; Outer Diameter 6.5 mm
Prescription: yes; Single use: yes
On the market
Erisma™-LP 18016545
Clariance, Inc.
18016545 / 1801654503700780605170
Length 45 mm; Outer Diameter 6.5 mm
Prescription: yes; Single use: yes
On the market
Erisma™-LP 18017530
Clariance, Inc.
18017530 / 1801753003700780605231
Length 30 mm; Outer Diameter 7.5 mm
Prescription: yes; Single use: yes
On the market
Erisma™-LP 18018550
Clariance, Inc.
18018550 / 1801855003700780605439
Length 50 mm; Outer Diameter 8.5 mm
Prescription: yes; Single use: yes
On the market
Erisma™-LP 18018565
Clariance, Inc.
18018565 / 1801856503700780605460
Length 65 mm; Outer Diameter 8.5 mm
Prescription: yes; Single use: yes
On the market
Erisma™-LP 18019545
Clariance, Inc.
18019545 / 1801954503700780605552
Length 45 mm; Outer Diameter 9.5 mm
Prescription: yes; Single use: yes
On the market
Erisma™-LP 18019575
Clariance, Inc.
18019575 / 1801957503700780605613
Length 75 mm; Outer Diameter 9.5 mm
Prescription: yes; Single use: yes
On the market
Erisma™-LP 18031060
Clariance, Inc.
18031060 / 1803106003700780612109
Length 60 mm; Outer Diameter 10.5 mm
Prescription: yes; Single use: yes
On the market
Erisma™-LP 18037550
Clariance, Inc.
18037550 / 1803755003700780606283
Length 50 mm; Outer Diameter 7.5 mm
Prescription: yes; Single use: yes
On the market
Erisma™-LP 18037580
Clariance, Inc.
18037580 / 1803758003700780606344
Length 80 mm; Outer Diameter 7.5 mm
Prescription: no; Single use: yes
On the market
Erisma™-LP 18038530
Clariance, Inc.
18038530 / 1803853003700780611850
Length 30 mm; Outer Diameter 8.5 mm
Prescription: yes; Single use: yes
On the market
Erisma™-LP 18038535
Clariance, Inc.
18038535 / 1803853503700780611874
Length 35 mm; Outer Diameter 8.5 mm
Prescription: yes; Single use: yes
On the market
Erisma™-LP 18038555
Clariance, Inc.
18038555 / 1803855503700780611904
Length 55 mm; Outer Diameter 8.5 mm
Prescription: yes; Single use: yes
On the market
Erisma™-LP 18038580
Clariance, Inc.
18038580 / 1803858003700780611973
Length 80 mm; Outer Diameter 8.5 mm
Prescription: yes; Single use: yes
On the market
Erisma™-LP 18039510
Clariance, Inc.
18039510 / 1803951003700780612147
Length 100 mm; Outer Diameter 9.5 mm
Prescription: yes; Single use: yes
On the market
Erisma™-LP 18039555
Clariance, Inc.
18039555 / 1803955503700780612192
Length 55 mm; Outer Diameter 9.5 mm
Prescription: yes; Single use: yes
On the market
Erisma™-LP 18046535
Clariance, Inc.
18046535 / 1804653503700780606801
Length 35 mm; Outer Diameter 6.5 mm
Prescription: yes; Single use: yes
On the market
Erisma™-LP 18415105
Clariance, Inc.
18415105 / 1841510503700780645091
Length 105 mm; Outer Diameter 5.5 mm
Prescription: yes; Single use: yes
On the market
Erisma™-LP 18415512
Clariance, Inc.
18415512 / 1841551203700780608164
Length 120 mm; Outer Diameter 5.5 mm
Prescription: yes; Single use: yes
On the market
Erisma™-LP 18415585
Clariance, Inc.
18415585 / 1841558503700780645077
Length 85 mm; Outer Diameter 5.5 mm
Prescription: yes; Single use: yes
On the market
Erisma™-LP 18455509
Clariance, Inc.
18455509 / 1845550903700780611812
Length 90 mm; Outer Diameter 5.5 mm
Prescription: yes; Single use: yes
On the market
Erisma™-LP 18455520
Clariance, Inc.
18455520 / 1845552003700780608607
Length 200 mm; Outer Diameter 5.5 mm
Prescription: yes; Single use: yes
On the market
Spinal Instrument 99701075
Clariance, Inc.
99701075 / 9970107503700780610945
Outer Diameter 7.5 mm
Prescription: yes; Single use: no
On the market
Spinal Instrument 99701085
Clariance, Inc.
99701085 / 9970108503700780610952
Outer Diameter 8.5 mm
Prescription: yes; Single use: no
On the market
Spinal Instrument 99702000
Clariance, Inc.
99702000 / 9970200003700780611096
Prescription: yes; Single use: no
On the market
Spinal Instrument 99731000
Clariance, Inc.
99731000 / 9973100003700780611249
Prescription: yes; Single use: no
On the market
Spinal Instrument 99740002
Clariance, Inc.
99740002 / 9974000203700780628551
Prescription: yes; Single use: no
On the market
Spinal Instrument 99780000
Clariance, Inc.
99780000 / 9978000003700780611461
Prescription: yes; Single use: no
On the market
Spinal Instrument 99780001
Clariance, Inc.
99780001 / 9978000103700780611478
Prescription: yes; Single use: no
On the market
Spinal Instrument 99781100
Clariance, Inc.
99781100 / 9978110003700780611515
Prescription: yes; Single use: no
On the market

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