NA

Basic Information

• Brand Name: NA
• Primary DI: 10845854015698
• Version / Model: C2621
• Catalog Number: C2621
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-12-10
• Public Version: 4
• Public Version Date: 2024-02-12
• Public Version Status: Update
• Public Device Record Key: c4e6e47f-3aa5-408d-ae41-9d014ff2cb16

Device Description

17MM SPIKED WASHER, 1.3MM POST

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HTN	WASHER, BOLT NUT	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61670	Implantable bone washer	An implantable, flat ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic, spinal, and/or craniofacial bone fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10845854015698	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K954682	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	17	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: KEEP DRY