PathLoc-SI Joint Fusion System

GUDID 08806344363625

Locking Screw Ø 7.0 40mm

L&K BIOMED CO. ,LTD.

Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated Sacroiliac joint transarticular fixation/arthrodesis implant, coated

• Primary Device ID: 08806344363625
• NIH Device Record Key: 44ed8ea8-bc63-44f4-b376-3df8e0ab1ecb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PathLoc-SI Joint Fusion System
• Version Model Number: 1023-7040S
• Company DUNS: 631159324
• Company Name: L&K BIOMED CO. ,LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806344363625 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181600

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-11-28
• Device Publish Date: 2018-10-02

On-Brand Devices [PathLoc-SI Joint Fusion System]

• 08806344363809: Washer
• 08806344363793: Washer
• 08806344363786: Washer
• 08806344363779: Locking Screw Ø 8.0 70mm
• 08806344363762: Locking Screw Ø 8.0 65mm
• 08806344363755: Locking Screw Ø 8.0 60mm
• 08806344363748: Locking Screw Ø 8.0 55mm
• 08806344363731: Locking Screw Ø 8.0 50mm
• 08806344363724: Locking Screw Ø 8.0 45mm
• 08806344363717: Locking Screw Ø 8.0 40mm
• 08806344363700: Locking Screw Ø 8.0 35mm
• 08806344363694: Locking Screw Ø 8.0 30mm
• 08806344363687: Locking Screw Ø 7.0 70mm
• 08806344363670: Locking Screw Ø 7.0 65mm
• 08806344363663: Locking Screw Ø 7.0 60mm
• 08806344363656: Locking Screw Ø 7.0 55mm
• 08806344363649: Locking Screw Ø 7.0 50mm
• 08806344363632: Locking Screw Ø 7.0 45mm
• 08806344363625: Locking Screw Ø 7.0 40mm
• 08806344363618: Locking Screw Ø 7.0 35mm
• 08806344363601: Locking Screw Ø 7.0 30mm
• 08806344363595: Locking Screw Ø 6.0 70mm
• 08806344363588: Locking Screw Ø 6.0 65mm
• 08806344363571: Locking Screw Ø 6.0 60mm
• 08806344363564: Locking Screw Ø 6.0 55mm
• 08806344363557: Locking Screw Ø 6.0 50mm
• 08806344363540: Locking Screw Ø 6.0 45mm
• 08806344363533: Locking Screw Ø 6.0 40mm
• 08806344363526: Locking Screw Ø 6.0 35mm
• 08806344363519: Locking Screw Ø 6.0 30mm
• 08806344363502: Arch Screw Close Type 70mm
• 08806344363496: Arch Screw Close Type 65mm
• 08806344363489: Arch Screw Close Type 60mm
• 08806344363472: Arch Screw Close Type 55mm
• 08806344363465: Arch Screw Close Type 50mm
• 08806344363458: Arch Screw Close Type 45mm
• 08806344363441: Arch Screw Close Type 40mm
• 08806344363434: Arch Screw Close Type 35mm
• 08806344363427: Arch Screw Close Type 30mm
• 08806344363410: Arch Screw Open Type 70mm
• 08806344363403: Arch Screw Open Type 65mm
• 08806344363397: Arch Screw Open Type 60mm
• 08806344363380: Arch Screw Open Type 55mm
• 08806344363373: Arch Screw Open Type 50mm
• 08806344363366: Arch Screw Open Type 45mm
• 08806344363359: Arch Screw Open Type 40mm
• 08806344363342: Arch Screw Open Type 35mm
• 08806344363335: Arch Screw Open Type 30mm
• 08806344363328: Locking Screw Ø 8.0 70mm
• 08806344363311: Locking Screw Ø 8.0 65mm