Who else makes this device?

Name: Tara Femoral Component 53
Brand: Tara Femoral Component 53

Orthopedic › ProstheticProsthesis, Hip, Femoral, Resurfacing

Tara Femoral Component 53

Catalogue number 10092, listed by Biopro, Inc., United States, under Prosthesis, Hip, Femoral, Resurfacing. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

Registered in Shanghai.

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

Record

Regulatory record for Tara Femoral Component 53
Listed by	Biopro, Inc., United States
FDA product code	KXA
Device type	Prosthesis, Hip, Femoral, Resurfacing
Device class	Class 2
Regulation	21 CFR 888.3400
Establishment	Contract manufacturer, Repacker / relabeller, Manufacturer
510(k)	K043542
Record published	2015-09-16
Record revised	2019-11-08 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Tara Femoral Component 53
Catalogue number	Size	Status
10092		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis	Corin Limited	150
Recap HIP System	Biomet Orthopedics	57
Prosthesis, Hip, Femoral, Resurfacing	Zimmer, Inc.	36
Conserve®	Microport Orthopedics Inc.	33
B-P Total HIP System	Endotec, Inc.	13
Synovo HIP Components	Synovo Production	11
Duramer®	Microport Orthopedics Inc.	10
Biocore9 Femoral Resurfacing Component	BIOCORE9 LLC	9
HemiCAP®	Arthrosurface, Inc.	8
Tara Femoral Component 43	Biopro, Inc.	1
Tara Femoral Component 41	Biopro, Inc.	1
Tara Femoral Component 38	Biopro, Inc.	1

Showing 12 of 16. All products under Prosthesis, Hip, Femoral, Resurfacing

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K043542	2005-05-18
K894604	1989-11-17

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.