Diplomat

by SIGNUS Medizintechnik GmbH 307 variants

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04047844036273 UDI-DI	Date29 Oct 2019Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK151704	Date13 Apr 2016Decided	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Spinal bone screw, non-bioabsorbable
Model / Ref / Catalog: Pedicle screw, fenestrated, reduction, monoaxial, incl. set screw, AB1331-95100/SX

Primary DI / UDI-DI: 04047844036273
510(k) Number: K151704
FDA product code: MNH, MNI, NKB
GMDN term: Spinal bone screw, non-bioabsorbable

Device class: Class II
Regulation number: 888.3070
GUDID distribution status: In Commercial Distribution

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See all devices from SIGNUS Medizintechnik GmbH →

Properties

Supplied sterile
Single use
Implantable
Prescription use
Lot / batch number
Expiration date
Manufacturing date

Other properties (8)

Sterilise before use: No
Contains latex: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Premarket exempt: No
Serial number: No