AccessGUDID - DEVICE: The Locking Pediatric Osteotomy Plate (LolliPOP) System (07540194004932)

GUDID

Device Identifier (DI) Information

Brand Name: The Locking Pediatric Osteotomy Plate (LolliPOP) System
Version or Model: POP-AVR-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: POP-AVR-100
Company Name: Pega Medical Inc

Primary DI Number: 07540194004932
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 257315713 *Terms of Use

Device Description: Varus Plate, Adolescent 100°

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?
66943	Femoral fixation plate/blade	An implantable, non-customized sheet of firm material that incorporates a blade at one end designed to be attached with screws to the proximal and/or distal femur to treat a fracture; the blade is intended to be introduced into the bone to assist with fixation. It is made of non-bioabsorbable materials (e.g., surgical steel, titanium alloy) and is available is various blade angles/sizes. Instruments intended to facilitate implantation (e.g., driver), or plate fixation implants (i.e., bone screws), may be included with the plate/blade.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KTT	APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170704	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
Special Storage Condition, Specify: keep at room temperature

Clinically Relevant Size

[?]

Size Type Text
Angle: 100 degree

Device Record Status

Public Device Record Key: d56c25b1-4464-44a3-bdde-08286b53a590
Public Version Date: June 26, 2024
Public Version Number: 5
DI Record Publish Date: November 03, 2017