Fixation Device
ProTack - 174006
Device Description
A collection of devices designed to implant a non-bioabsorbable fixation anchor into ligaments or other soft tissues to serve as a site of attachment for surgical binding materials (e.g., mesh, sutures). The set typically consists of non-bioabsorbable fixation anchors, possibly contained within a cartridge, and a mechanical applicator used to hold, position, and insert each anchor into the target tissue; and possibly a drill or punch to create the hole to deliver the anchor. This is a single-patient device.
Environmental Conditions
No Data Available
Device Sizes
- Outer Diameter: 5 Millimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: GCJ
Device Name: Laparoscope, General & Plastic Surgery
Device Class: 2
Physical State: N/A
Definition: Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Submission Type ID: 1
Review Panel: SU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 876.1500
Third Party Flag: N
Medical Specialty: GU
Device IdentifiersDevice Id: 20884521070407
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10884521070400
Package Quantity: 6
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: CASE
Device Id: 10884521070400
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A