Medtronic Sofamor Danek USA, Inc.: PMA supplement approved for Infuse TM Bone Graft/Medtronic lnterbody Fusion Device
Medtronic Sofamor Danek USA, Inc. (Memphis, Tennessee): PMA supplement approved for Infuse TM Bone Graft/Medtronic lnterbody Fusion Device. Dated 100 days ago, it serves as a historical benchmark. Score 30/100. As of 2026-11-04, from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
Free preview: all 8 published fields of this record are shown below. Locked: 7 related TN FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Medtronic Sofamor Danek USA, Inc. |
| Product | Infuse TM Bone Graft/Medtronic lnterbody Fusion Device |
| Generic / ingredient | Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction |
| Approval | PMA supplement (device change) |
| Application | P000058 S099 |
| Decided | 2026-07-28 |
| Panel / class | Orthopedic |
| Sponsor location | Memphis, TN |
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CSV columns: Sponsor · Product · Approval · Decided · official source URL
- Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
- Record date: 2026-07-28
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FdaApprovalPulse records (TN first): Medtronic, Inc. · Medtronic Sofamor Danek USA, Inc. · Medtronic Sofamor Danek USA, Inc. · Lynch Biologics, LLC · Medtronic Sofamor Danek USA, Inc. · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 06:06:18 GMT
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Peer benchmark and outreach value: Medtronic Sofamor Danek USA, Inc. and 8 Tennessee peers
- Tennessee FdaApprovalPulse records like this one: 8
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Tennessee peer: $1,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Score
What is the FdaApprovalPulse record for Medtronic Sofamor Danek USA, Inc. in Memphis, Tennessee?
The FDA approved Infuse TM Bone Graft/Medtronic lnterbody Fusion Device (P000058 S099) for Medtronic Sofamor Danek USA, Inc. on 2026-07-28: PMA supplement (device change).
How does Medtronic Sofamor Danek USA, Inc. compare to other Tennessee FdaApprovalPulse records?
It is 100 days old; check the official source for later updates before acting. Its Score of 30/100 is modest; treat it as background rather than a priority.
Medtronic Sofamor Danek USA, Inc. vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Medtronic Sofamor Danek USA, Inc. | Memphis, TN | 2026-07-28 |
| Instylla, Inc. | Bedford, MA | 2026-10-23 |
| Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | Tucson, AZ | 2026-10-23 |
| Cerenovus, Inc. | Miami, FL | 2026-10-23 |
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From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.