Who else makes this device?

Name: 13 X 85mm LAG Fastener
Brand: 13 X 85mm LAG Fastener

Orthopedic › ProstheticDevice, Fixation, Proximal Femoral, Implant

13 X 85mm LAG Fastener

Catalogue number 324-13085, listed by OsteoCentric Technologies,Inc, United States, under Device, Fixation, Proximal Femoral, Implant. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

All of them in Shanghai. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code JDO
Manufacturer	City	Province	Registered as	Device types
LX Precision Shanghai Co Ltd	Shanghai	Shanghai	Contract manufacturer	19
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106

Record

Regulatory record for 13 X 85mm LAG Fastener
Listed by	OsteoCentric Technologies,Inc, United States
FDA product code	JDO
Device type	Device, Fixation, Proximal Femoral, Implant
Device class	Class 2
Regulation	21 CFR 888.3030
Establishment	Specification developer, Complaint-file establishment, Manufacturer
510(k)	K230764
Record published	2025-09-22

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
Sizes	Outer diameter 13 mm; length 85 mm

Catalogue Numbers

Catalogue numbers for 13 X 85mm LAG Fastener
Catalogue number	Size	Status
324-13085	Outer Diameter 13 mm	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
BMP Compression HIP Screw	Biomet Orthopedics	112
DHS	Synthes Gmbh	93
THP™ Hip Fracture Plating System	Biomet Orthopedics	74
Percutaneous Compression Plate (Pc.c.p)	Orthofix SRL	69
Proform Hip System	Globus Medical, Inc.	51
Conquest FN	Smith & Nephew, Inc.	31
CHS	Smith & Nephew, Inc.	26
Large Cannulated Screws	Smith & Nephew, Inc.	22
TSP HIP FX Plating SYSTEM4.5MM Cortical NON – Locking Screw	Biomet Orthopedics	13
TSP HIP FX Plating SYSTEM4.5MM Cortical Locking Screw	Biomet Orthopedics	12
TSP HIP FX Plating SYSTEM7.5MM Telescoping LAG Screw	Biomet Orthopedics	6
Dhhs	Synthes Gmbh	6

Showing 12 of 112. All products under Device, Fixation, Proximal Femoral, Implant

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K230764	2023-04-18

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.