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Erisma™-LP 18415105

by Clariance, Inc.

Erisma™-LP 18415105 is a Class II device made by Clariance, Inc., cleared under FDA 510(k) K120469 on 13 Aug 2012 and listed in FDA GUDID since 2 Dec 2024 (UDI-DI 03700780645091), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K120469

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03700780645091 UDI-DI Date2 Dec 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK120469 Date13 Aug 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K120469 decided 13 Aug 2012 Active
  • FDA GUDID UDI-DI 03700780645091 listed 2 Dec 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K120469
  2. Listed FDA GUDID 03700780645091

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Erisma™-LP
Generic name
Bone-screw internal spinal fixation system rod
Model / Ref / Catalog
18415105
Primary DI / UDI-DI
03700780645091
510(k) Number
FDA product code
NKB, MNI, MNH
GMDN term
Bone-screw internal spinal fixation system rod
Device class
Class II
Regulation number
888.3070
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Length — 105 Millimeter
Outer Diameter — 5.5 Millimeter

Related devices

Category: Bone-screw internal spinal fixation system rod

Cleared under the same submission (K120469)

and 8 more cleared under K120469

Similar devices

Other devices filed under FDA product code NKB (Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease).

Other devices from Clariance, Inc.

See all devices from Clariance, Inc. →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (9, all answered No)