Who else makes this device?

Name: Distraction, Internal
Brand: Distraction, Internal

Orthopedic › ProstheticComponent, Traction, Invasive

Distraction, Internal

Dist, Finger, Zurich 1, Genos MC, Front DRV, Rigid ACT ARM, 2.0-2.3 MM Screw, TI-6AL-4V

Registry build 21.09.26

1manufacturer

9catalogue numbers in this listing

1510(k) clearance

Who Else Makes It

Registered in Shanghai.

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

Record

Regulatory record for Distraction, Internal
Listed by	KLS-Martin L.P., United States
FDA product code	JEC
Device type	Component, Traction, Invasive
Device class	Class 2
Regulation	21 CFR 888.3040
Establishment	Specification developer, Manufacturer
Record published	2016-03-24
Record revised	2023-10-19 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for Distraction, Internal
Catalogue number	Size	Status
26-706-18-09	18 MM, 4 HOLE	In distribution
26-702-15-09	15 MM, 4 HOLE	In distribution
26-702-25-09	25 MM, 4 HOLE	In distribution
26-704-23-09	23 MM, 8 HOLE	In distribution
26-706-19-09	18 MM, 4 HOLE	In distribution
26-702-30-09	30 MM, 4 HOLE	In distribution
26-702-20-09	20 MM, 4 HOLE	In distribution
26-706-24-09	23 MM, 4 HOLE	In distribution
26-706-23-09	23 MM, 4 HOLE	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Medline	Medline Industries, Inc.	115
Fragment Fixation System	Orthofix SRL	77
Anjon Bremer Halo System	Anjon Holdings, LLC	68
Sheffield Ring Fixator	Orthofix SRL	68
Hoffmann	Stryker GmbH	65
Hybrid Fixator System	Orthofix SRL	30
Triax	Stryker GmbH	26
Bremer	Depuy Spine, Inc.	11
Additional Accessories FOR THE Orthofix System	Orthofix SRL	10
Component, Traction, Invasive	Synthes Gmbh	9
Halo Systems	Ossur Americas	4
DigiFix	Virak Orthopedics LLC	3

Showing 12 of 65. All products under Component, Traction, Invasive

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K042066	2004-08-25

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.