AccessGUDID - DEVICE: Ascend (00190376518428)

GUDID

Device Identifier (DI) Information

Brand Name: Ascend
Version or Model: 153-12-R-180010-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ALPHATEC SPINE, INC.

Primary DI Number: 00190376518428
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 602465783 *Terms of Use

Device Description: 12 mm CORE ENDPLATE, RND 18 mm 10°

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?
34170	Vertebral body prosthesis	An implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PLR	Spinal vertebral body replacement device - Cervical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K232173	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
Outer Diameter: 18 Millimeter
Angle: 10 degree

Device Record Status

Public Device Record Key: d76814e5-ae53-41c4-b958-fe8ebf8f4533
Public Version Date: November 05, 2024
Public Version Number: 1
DI Record Publish Date: October 28, 2024

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: Yes
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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(760)431-9286
Email: Regulatory@alphatecspine.com

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

FDA TOOLS & RESOURCES