AccessGUDID - DEVICE: HammerTube System (00889795057679)

GUDID

Device Identifier (DI) Information

Brand Name: HammerTube System
Version or Model: P40-002-0350-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P40-002-0350-S
Company Name: Paragon 28, Inc.

Primary DI Number: 00889795057679
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042961576 *Terms of Use

Device Description: HammerTube Implant, 3.50mm, 10° Cannulated

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
61687	Phalangeal joint arthrodesis implant	A small, non-bioabsorbable, implantable device of fixed-length designed to be inserted within a phalangeal joint (i.e., not a plate) in the finger and/or toe (i.e., interphalangeal or phalangeal/metacarpal/metatarsal) to fuse the joint (arthrodesis), typically to manage arthritis or deformities (e.g., hammer toe), or for arthroplasty revision; it is not intended for carpal, tarsal or ankle implantation. It is typically made of metal and can be of several small designs (e.g., rod with barbs at each end, X-shaped, single or dual screw), however it is not intended to be fixed into bone with bone screws (i.e., not an intramedullary nail).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HTY	PIN, FIXATION, SMOOTH

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K171715	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
No Device Sizes

Device Record Status

Public Device Record Key: 014d2cbf-7fa5-4650-9644-93c41dda6b09
Public Version Date: April 22, 2025
Public Version Number: 4
DI Record Publish Date: October 17, 2019