AccessGUDID - DEVICE: Zavation (00197157004484)

GUDID

Device Identifier (DI) Information

Brand Name: Zavation
Version or Model: 770-12555
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Zavation LLC

Primary DI Number: 00197157004484
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 069472800 *Terms of Use

Device Description: Posterior Lateral Screw 12.5mmx55mm

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58733	Sacroiliac joint intra-articular arthrodesis implant	An implantable device designed to achieve and maintain the distraction of degenerated articular surfaces of the sacroiliac joint to assist in intra- and extra-articular bone grafting and fusion (arthrodesis), typically performed to alleviate pain from the sacroiliac joints in skeletally mature patients. The device is a tapered tube made of titanium alloy which has radial fenestrations to encourage bony in-growth. It is surgically implanted under fluoroscopic guidance using an assortment of dedicated tools. It is available in several sizes and intended for permanent implantation.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OUR	Sacroiliac Joint Fixation
HWC	Screw, Fixation, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K173752	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 34cfa787-48f8-4f2b-ac21-697d42c92e70
Public Version Date: April 26, 2024
Public Version Number: 2
DI Record Publish Date: April 04, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 601-919-1119
Email: info@zavation.com

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