AccessGUDID - DEVICE: ZIP (B521001014MZIP0)

GUDID

Device Identifier (DI) Information

Brand Name: ZIP
Version or Model: ULTRA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 001-014-M-ZIP
Company Name: AURORA SPINE, INC.

Primary DI Number: B521001014MZIP0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079119091 *Terms of Use

Device Description: ZIP ULTRA MIS Interspinous Fusion System, 14mm x 40mm

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:	Yes
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?
61688	Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile	A sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
PEK	Spinous Process Plate

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140715	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 40 Millimeter
Lumen/Inner Diameter: 14 Millimeter

Device Record Status

Public Device Record Key: 73f5cab7-cba5-472e-8589-3c2571155884
Public Version Date: February 19, 2024
Public Version Number: 2
DI Record Publish Date: March 01, 2019

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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 760.424.2004
Email: info@auroraspine.us

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES