Dsc-34PK0

by Sintea Plustek, LLC

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 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number08033726408142 UDI-DI	Date9 Oct 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK070181	Date18 Apr 2007Decided	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Dsc
Generic name: Metallic spinal fusion cage, non-sterile
Model / reference: DSC-34PK0

Primary DI / UDI-DI: 08033726408142
510(k) Number: K070181
FDA product code: MQP
GMDN term: Metallic spinal fusion cage, non-sterile

Device class: Class II
Regulation number: 888.3060
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization
MRI safety: MR Unsafe

Other devices from Sintea Plustek, LLC

Pls-10090T57

Class II
Pls-48T5120

Class II
Pls-440T57

Class II
Pls-550T56

Class II
Pls-530T540

Class II
Pls-5085T58

Class II

See all devices from Sintea Plustek, LLC →

Properties

Sterilise before use
Single use
Lot / batch number

Other properties (12)

Supplied sterile: No
Implantable: No
Contains latex: No
Prescription use: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Premarket exempt: No
Serial number: No
Expiration date: No
Manufacturing date: No