Modal Total Hip System M-EBS-6530

by Modal Manufacturing 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	NumberB035MEBS65301 UDI-DI	Date1 Jul 2018Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK143314	Date27 Feb 2015Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K143314

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Withdrawn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: Modal Total Hip System
Generic name: Metal-on-polyethylene total hip prosthesis
Model / reference: M-EBS-6530

Primary DI / UDI-DI: B035MEBS65301
510(k) Number: K143314
FDA product code: LZO, LPH
GMDN term: Metal-on-polyethylene total hip prosthesis

Device class: Class II
Regulation number: 888.3353, 888.3358
GUDID distribution status: In Commercial Distribution

Other devices from Modal Manufacturing LLC

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Modal Total Knee System Rev A

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Modal Total Knee System M-3301-2046

Class II
Modal Total Hip System M-1300-3602

Class II
Modal Total Knee System M-3311-2011

Class II
Modal Total Knee System M-3301-1021

Class II

See all devices from Modal Manufacturing LLC →

Properties

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

Other properties (9)

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
Manufacturing date: No