AccessGUDID - DEVICE: 3P Hip System (00840194480871)

GUDID

Device Identifier (DI) Information

Brand Name: 3P Hip System
Version or Model: 00-3001-1264
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00-3001-1264
Company Name: ORTHOPEDIATRICS CORP.

Primary DI Number: 00840194480871
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 796416191 *Terms of Use

Device Description: 120° Infant Offset Plate, 4-Hole, 6mm Offset

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
66945	Femoral neck fixation plate/sleeve	An implantable, non-bioabsorbable, non-customized sheet of firm material that incorporates a sleeve (commonly known as a barrel) at its proximal end designed to be attached with screws to the proximal femur to treat a femoral neck (trochanteric) fracture. The sleeve is intended to be introduced into the bone to hold a sliding screw (commonly known as a lag or dynamic screw) and/or a deployable-hook pin [not included] that is implanted into the femoral head/neck to compress the fracture. It is available in various sleeve angles/sizes. Instruments intended to facilitate implantation (e.g., driver), or plate fixation implants (i.e., cortical bone screws), may be included with the plate/sleeve.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HRS	Plate, fixation, bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K243963	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
No Device Sizes

Device Record Status

Public Device Record Key: 0c8dd0ba-129d-4809-83e1-b775c7f47a09
Public Version Date: June 27, 2025
Public Version Number: 1
DI Record Publish Date: June 19, 2025

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

Customer Contact

[?]

Phone: +1(574)268-6379
Email: xxx@xxx.com

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