AccessGUDID - DEVICE: Redondo-L™ (10889981035211)

GUDID

Device Identifier (DI) Information

Brand Name: Redondo-L™
Version or Model: 36-5114
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 36-5114
Company Name: SEASPINE ORTHOPEDICS CORPORATION

Primary DI Number: 10889981035211
Issuing Agency: GS1
Commercial Distribution End Date: September 02, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 079840876 *Terms of Use

Device Description: Redondo-L 45mm x 18mm x 8mm, 8 Deg. Redondo-L is intended to promote spinal fusion by acting as a spacer and holding bone graft. The implants have teeth on the superior and inferior surfaces and a central canal for receiving bone graft. These devices are available in a variety of lengths, widths, and heights to accommodate variations in pathology and patient anatomy. All Redondo-L implants are manufactured from PEEK OPTIMA®(polyetheretherketone, ASTM F-2026) with tantalum (ASTM F-560) radiographic wires and/or beads.

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?
57806	Vertebral body prosthesis, non-sterile	A non-sterile implantable device designed to replace or repair (fuse) the spinal bony segments, or vertebrae, lost or injured as a consequence of, e.g., trauma, deformity, tumour, or degenerative disease. It is typically intended to be used with supplemental spinal fixation and may be used with a bone graft. It is usually made of metal, polymer, or a combination of these materials. This device must be sterilized prior to use.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MQP	SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
MAX	Intervertebral fusion device with bone graft, lumbar

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K103297	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
Device Size Text, specify: 50mm x 18mm x 14mm, 0 degrees

Device Record Status

Public Device Record Key: 5e6df64f-f6a1-413c-97d1-33e70207780c
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2015