Identity
- Trade Name
- ProDisc FDA UDI
- Generic Name
- Lumbar total intervertebral disc prosthesis FDA UDI
- Device Name
- POLYETHYLENE INLAY W/TANTALUM MARKER/LARGE-14MM-STERILE FDA UDI
- Model / Reference
- PDL-L-PT14S FDA UDI
- Description
- POLYETHYLENE INLAY W/TANTALUM MARKER/LARGE-14MM-STERILE FDA UDI
Identifiers
- Catalog Number
- PDLLPT14S FDA UDI
- Primary DI / UDI-DI
- 10705034700069 FDA UDI
- PMA Number
- P050010 FDA UDI
- FDA Product Code
- MJO FDA UDI
- GMDN Term
- Lumbar total intervertebral disc prosthesis FDA UDI
Classification
- Device Class
- Class III 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
No
FDA UDI
MR Conditional FDA UDI
Category: Lumbar total intervertebral disc prosthesis
ProDisc by Synthes (u.s.a.) Lp — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lumbar total intervertebral disc prosthesis.
- Prodisc L — Centinel Spine, LLC · Class III
- activL® — AESCULAP, INC. · Class III
- 3DP Lumbar Interbody — Genesys Orthopedics Systems LLC · Class II
- Prodisc L — Centinel Spine, LLC · Class III
- activL® — AESCULAP, INC. · Class III
- activL® — AESCULAP, INC. · Class III
- Brickyard Stand-Alone ALIF — Altus Spine · Class II
- activL® — AESCULAP, INC. · Class III
Cleared under the same submission
P050010 also covers:
- Prodisc L — Centinel Spine, LLC
- Prodisc L — Centinel Spine, LLC
- Prodisc L — Centinel Spine, LLC
- Prodisc L — Centinel Spine, LLC
- Prodisc L — Centinel Spine, LLC
- Prodisc L — Centinel Spine, LLC
- Prodisc L — Centinel Spine, LLC
- Prodisc L — Centinel Spine, LLC
- Prodisc L — Centinel Spine, LLC
- Prodisc L — Centinel Spine, LLC
- Prodisc L — Centinel Spine, LLC
- Prodisc L — Centinel Spine, LLC
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 III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Synthes (u.s.a.) Lp
Sources (1)
- FDA UDI de4655f3-4525-41a4-af19-5b6a0589088e 36 fields · synced Jun 6, 2026