Delta Ceramic Femoral Head 136-4030

by Ortho Development Corp.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 23 Oct 2026

Documents

None

No authorization documents

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	Number00822409034956 UDI-DI	Date16 Aug 2016Listed	StatusListed GUDID: in commercial distribution

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Withdrawn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 — GUDID listing Listed

Specification

GUDID

Trade Name: Delta Ceramic Femoral Head
Generic Name: Coated hip femur prosthesis, modular
Model / Reference: 136-4030

Primary DI / UDI-DI: 00822409034956
510(k) Number: K111936
FDA Product Code: LZO
GMDN Term: Coated hip femur prosthesis, modular

Device Class: Class II
Regulation Number: 888.3353
GUDID distribution status: In Commercial Distribution

Size: Outer Diameter — 40 Millimeter

Other devices from Ortho Development Corp.

N/A 228-0031

Class I
N/A 233-0138

Class I
N/A 233-0139

Class I
N/A 233-0140

Class I
N/A 233-0142

Class I
N/A 233-0141

Class I

See all devices from Ortho Development Corp. →

Properties

Sterile
Single Use
Implantable
Prescription Use
Lot / Batch Number
Expiration Date

Other properties (8)

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