AccessGUDID - DEVICE: Integra® (10381780257660)

GUDID

Device Identifier (DI) Information

Brand Name: Integra®
Version or Model: LMP-20T
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780257660
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 942377524 *Terms of Use
Previous DI: 00846832006625

Device Description: LMP Implant Size 20 The Integra® Lesser Metatarsal Phalangeal Joint Implant is the first prosthesis designed specifically to supplement lesser metatarsal phalangeal joint arthroplasty. Constructed of medical grade silicone elastomer, the implant features stems designed to fit the intramedullary canals of the proximal phalanx and the lesser metatarsal. The LMP is offered in four sizes and is supported by a custom instrumentation set.

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?
33700	Total metatarsophalangeal joint prosthesis, one-piece	An implantable device designed to replace the metatarsophalangeal (MTP) joint(s) of the foot (toe). The device is made of a single piece of silicone elastomer. It is is intended to treat degenerative or traumatic arthritis, hallux valgus, hallus rigidus, and/or an unstable or painful MTP joint.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWH	PROSTHESIS, TOE, CONSTRAINED, POLYMER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K023531	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
Device Size Text, specify: 20

Device Record Status

Public Device Record Key: a023bf4e-5bc4-4a10-b8c8-a5e7cd861b97
Public Version Date: January 25, 2023
Public Version Number: 6
DI Record Publish Date: July 25, 2016