Identity
- Trade Name
- MEDPOR FDA UDI
- Generic Name
- Orbital sphere implant FDA UDI
- Device Name
- Sphere with Enucleation Implant Inserter FDA UDI
- Model / Reference
- 6317 FDA UDI
- Description
- Sphere with Enucleation Implant Inserter FDA UDI
Identifiers
- Catalog Number
- 6317 FDA UDI
- Primary DI / UDI-DI
- 07613252083375 FDA UDI
- 510(k) Number
- K832283 FDA UDI
- FDA Product Code
- FWP FDA UDI
- GMDN Term
- Orbital sphere implant FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3550 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orbital sphere implant
Medpor by Stryker Leibinger — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orbital sphere implant.
- Bio-Eye® — INTEGRATED ORBITAL IMPLANTS, INC. · Class II
- Orbital sphere implant — FCI S A S FCI 20 22 · Class II
- EZYPOR® Ø 20 mm — FCI S A S FCI 20 22 · Class II
- 20mm Eye Sphere (non-sterile) — Gulden Ophthalmics · Class II
- Ambler Surgical — Ambler Surgical, LLC · Class II
- EZYPOR® Ø 16 mm — FCI S A S FCI 20 22 · Class II
- Orbital sphere implant — FCI S A S FCI 20 22 · Class II
- 22mm Sterile Orbital Implant (PMMA) — Gulden Ophthalmics · Class II
Cleared under the same submission
K832283 also covers:
- MEDPOR — Stryker Leibinger
- MEDPOR — Stryker Leibinger
- MEDPOR — Stryker Leibinger
- MEDPOR — Stryker Leibinger
- MEDPOR — Stryker Leibinger
- MEDPOR — Stryker Leibinger
- MEDPOR — Stryker Leibinger
- MEDPOR — Stryker Leibinger
- MEDPOR — Stryker Leibinger
- MEDPOR — Stryker Leibinger
- MEDPOR — Stryker Leibinger
- MEDPOR — Stryker Leibinger
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stryker Leibinger
Sources (1)
- FDA UDI 32939eed-867a-4272-b8ab-e4c89a4c393a 36 fields · synced May 30, 2026