AccessGUDID - DEVICE: primaLOK SP (00813210021754)

GUDID

Device Identifier (DI) Information

Brand Name: primaLOK SP
Version or Model: 800-0112-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Wenzel Spine, Inc.

Primary DI Number: 00813210021754
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 832543255 *Terms of Use

Device Description: primaLOK SP 12mm Implant Assembly, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as ack pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.

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?
46649	Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial	A collection of small sheets of firm material and bone screws intended to be implanted onto fractured bone fragments to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals. The components are made of a material that is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre); it does not include an antimicrobial agent(s). Tools for implantation may be included. The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion).	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KWP	Appliance, Fixation, Spinal Interlaminal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100354	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
Special Storage Condition, Specify: Room Temperature; Keep Dry

Clinically Relevant Size

[?]

Size Type Text
Height: 12 Millimeter

Device Record Status

Public Device Record Key: c17b112b-7d12-48ee-b1dc-63c2413d055e
Public Version Date: February 19, 2024
Public Version Number: 4
DI Record Publish Date: June 11, 2018