PMA
P000058: INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE
FDA PMA · Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction · Medtronic Sofamor Danek USA, Inc.
Key facts
| PMA number | P000058 |
|---|---|
| Trade name | INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE |
| Generic name | Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction |
| Applicant | Medtronic Sofamor Danek USA, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | NEK |
| Approval date | Jul 2, 2002 |
| Docket number | 02M-0310 |
| Notice date | Jul 11, 2002 |
| Establishment registration | 1030489 |
| FEI number | 1000477302 |
At a glance
- 10–99 Supplements
- Aug 26, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: