PathLoc SI Joint Fusion System BS65-0070

GUDID 08806344398252

Locking Screw (Cancellous Screw)

L&K BIOMED CO. ,LTD.

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

• Primary Device ID: 08806344398252
• NIH Device Record Key: e05f838d-2f7f-45e4-a1cf-987e998cb103
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PathLoc SI Joint Fusion System
• Version Model Number: BS65-0070
• Catalog Number: BS65-0070
• Company DUNS: 631159324
• Company Name: L&K BIOMED CO. ,LTD.
• Device Count: 1
• DM Exempt: true
• 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: false
• 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	08806344398252 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240201

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

[08806344398252]

Moist Heat or Steam Sterilization

[08806344398252]

Moist Heat or Steam Sterilization

[08806344398252]

Moist Heat or Steam Sterilization

[08806344398252]

Moist Heat or Steam Sterilization

[08806344398252]

Moist Heat or Steam Sterilization

[08806344398252]

Moist Heat or Steam Sterilization

[08806344398252]

Moist Heat or Steam Sterilization

[08806344398252]

Moist Heat or Steam Sterilization

[08806344398252]

Moist Heat or Steam Sterilization

[08806344398252]

Moist Heat or Steam Sterilization

[08806344398252]

Moist Heat or Steam Sterilization

[08806344398252]

Moist Heat or Steam Sterilization

[08806344398252]

Moist Heat or Steam Sterilization

[08806344398252]

Moist Heat or Steam Sterilization

[08806344398252]

Moist Heat or Steam Sterilization

[08806344398252]

Moist Heat or Steam Sterilization

[08806344398252]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-24
• Device Publish Date: 2024-04-16

On-Brand Devices [PathLoc SI Joint Fusion System]

• 08806344398351: Arch Screw (Bullet Type)
• 08806344398344: Arch Screw (Bullet Type)
• 08806344398337: Arch Screw (Bullet Type)
• 08806344398320: Arch Screw (Bullet Type)
• 08806344398313: Arch Screw (Bullet Type)
• 08806344398306: Arch Screw (Bullet Type)
• 08806344398290: Arch Screw (Bullet Type)
• 08806344398283: Arch Screw (Bullet Type)
• 08806344398276: Arch Screw (Bullet Type)
• 08806344398269: Washer
• 08806344398252: Locking Screw (Cancellous Screw)
• 08806344398245: Locking Screw (Cancellous Screw)
• 08806344398238: Locking Screw (Cancellous Screw)
• 08806344398221: Locking Screw (Cancellous Screw)
• 08806344398214: Locking Screw (Cancellous Screw)
• 08806344398207: Locking Screw (Cancellous Screw)
• 08806344398191: Locking Screw (Cancellous Screw)
• 08806344398184: Locking Screw (Cancellous Screw)
• 08806344398177: Locking Screw (Cancellous Screw)
• 08806344398160: Locking Screw (Cancellous Screw)
• 08806344398153: Locking Screw (Cancellous Screw)
• 08806344398412: Locking Screw (Cannulated Screw)
• 08806344398405: Locking Screw (Cannulated Screw)
• 08806344398399: Locking Screw (Cannulated Screw)
• 08806344398382: Locking Screw (Cannulated Screw)
• 08806344398375: Locking Screw (Cannulated Screw)
• 08806344398368: Locking Screw (Cannulated Screw)
• 08806344398658: Washer
• 08806344398641: Locking Screw (Cancellous Screw)
• 08806344398634: Locking Screw (Cancellous Screw)
• 08806344398627: Locking Screw (Cancellous Screw)
• 08806344398610: Locking Screw (Cancellous Screw)
• 08806344398603: Locking Screw (Cancellous Screw)
• 08806344398580: Locking Screw (Cancellous Screw)
• 08806344398573: Locking Screw (Cancellous Screw)
• 08806344398566: Locking Screw (Cancellous Screw)
• 08806344398559: Locking Screw (Cancellous Screw)
• 08806344398542: Locking Screw (Cancellous Screw)
• 08806344398535: Locking Screw (Cannulated Screw)
• 08806344398528: Locking Screw (Cannulated Screw)
• 08806344398511: Locking Screw (Cannulated Screw)
• 08806344398504: Locking Screw (Cannulated Screw)
• 08806344398481: Locking Screw (Cannulated Screw)
• 08806344398474: Locking Screw (Cannulated Screw)
• 08806344398467: Locking Screw (Cannulated Screw)
• 08806344398450: Locking Screw (Cannulated Screw)
• 08806344398443: Locking Screw (Cannulated Screw)
• 08806344398436: Locking Screw (Cannulated Screw)
• 08806344398429: Locking Screw (Cannulated Screw)