Skip to content

OTIS-C PLUS Plate - Left

by S.B.M

OTIS-C PLUS Plate - Left (EVO9067722) is a Class II device made by S.B.M, cleared under FDA 510(k) K120818 on 19 Apr 2012 and listed in FDA GUDID since 16 Oct 2015 (UDI-DI 03760154005135), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K120818

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03760154005135 UDI-DI Date16 Oct 2015ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK120818 Date19 Apr 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K120818 decided 19 Apr 2012 Active
  • FDA GUDID UDI-DI 03760154005135 listed 16 Oct 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K120818
  2. Listed FDA GUDID 03760154005135

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Otis-C Plus
Generic name
Orthopaedic fixation plate, non-bioabsorbable
Model / Ref / Catalog
OTIS-C PLUS Plate - Left, EVO9067722
Primary DI / UDI-DI
03760154005135
510(k) Number
FDA product code
HRS
GMDN term
Orthopaedic fixation plate, non-bioabsorbable
Device class
Class II
Regulation number
888.3030
GUDID distribution status
Not in Commercial Distribution

Other devices from S.B.M

See all devices from S.B.M →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)