FDA UDI
In Commercial Distribution
🇺🇸 United States
Integra®
DI: 10381780257677
·
Model: LMP-30T
·
Ascension Orthopedics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Integra®
- Primary DI
- 10381780257677
- Version / Model
- LMP-30T
- Company Name
- Ascension Orthopedics, Inc.
- Labeler DUNS
- 942377524
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-25
- Public Version
- 6
- Public Version Date
- 2023-01-25
- Public Version Status
- Update
- Public Device Record Key
- 7ca84169-9b1c-45d7-bfdb-4415a8b2563b
- Distribution End Date
- 2026-12-31
Device Description
LMP Implant Size 30 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
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KWH | PROSTHESIS, TOE, CONSTRAINED, POLYMER | Orthopedic | 888.3720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10381780257677 | GS1 | ||||
| Previous | 00846832006632 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K023531 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 30 |