Who else makes this device?

Name: Latitude
Brand: Latitude

Latitude · Prosthesis, Elbow, Constrained, Cemented → Orthopedic

1manufacturer

2catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Registered in Shanghai.

Chinese manufacturers registered for FDA product code JDC
Manufacturer	City	Province	Registered as	Device types
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106

Record

Regulatory record for Latitude
Listed by	Tornier Inc., United States
FDA product code	JDC
Device type	Prosthesis, Elbow, Constrained, Cemented
Device class	Class 2
Regulation	21 CFR 888.3150
Establishment	Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter
Record published	2019-05-08
Record revised	2024-09-11 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Prescription	Prescription only
Label carries	lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Latitude
Catalogue number	Size	Status
9030395		In distribution
9030398		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Nexel®	Zimmer, Inc.	78
DJO Surgical	Encore Medical, L.P.	74
Tema Elbow	Limacorporate	72
Discovery Elbow System	Biomet Orthopedics	72
Arcos Modular Revision Hip System	Biomet Orthopedics	58
Latitude™ – Elbow	Tornier Inc.	38
Prosthesis, Elbow, Constrained, Cemented	Zimmer, Inc.	37
Latitude™ EV	Tornier Inc.	36
Comprehensive® SRS	Biomet Orthopedics	31
Comprehensive® SRS Instrument	Biomet Orthopedics	30
Solar	Howmedica Osteonics Corp	27
Zimmer® Nexel® Total Elbow	Zimmer, Inc.	23

Showing 12 of 28. All products under Prosthesis, Elbow, Constrained, Cemented

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K000003	2000-10-02

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Latitude