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DIPLOMAT Tulip

by SIGNUS Medizintechnik GmbH

DIPLOMAT Tulip (AB0010-55001) is a Class II device made by SIGNUS Medizintechnik GmbH, cleared under FDA 510(k) K151704 on 13 Apr 2016 and listed in FDA GUDID since 14 Jun 2016 (UDI-DI 04047844020043), 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) K151704

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 Number04047844020043 UDI-DI Date14 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK151704 Date13 Apr 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K151704 decided 13 Apr 2016 Active
  • FDA GUDID UDI-DI 04047844020043 listed 14 Jun 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K151704
  2. Listed FDA GUDID 04047844020043

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Diplomat
Generic name
Spinal bone screw head/rod adaptor
Model / Ref / Catalog
Tulip, AB0010-55001
Primary DI / UDI-DI
04047844020043
510(k) Number
FDA product code
MNH, MNI, NKB
GMDN term
Spinal bone screw head/rod adaptor
Device class
Class II
Regulation number
888.3070
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Spinal bone screw head/rod adaptor

Cleared under the same submission (K151704)

and 8 more cleared under K151704

Similar devices

Other devices filed under FDA product code MNH (Orthosis, Spondylolisthesis Spinal Fixation).

Other devices from SIGNUS Medizintechnik GmbH

See all devices from SIGNUS Medizintechnik GmbH →

Properties

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