Dt Medtech, LLC: PMA supplement approved for Hintermann Series H3 Total Ankle Replacement System
Dt Medtech, LLC (Towson, Maryland): PMA supplement approved for Hintermann Series H3 Total Ankle Replacement System. Dated 97 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: 8 related MD FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Dt Medtech, LLC |
| Product | Hintermann Series H3 Total Ankle Replacement System |
| Generic / ingredient | Prosthesis, ankle, uncemented, non-constrained |
| Approval | PMA supplement (device change) |
| Application | P160036 S008 |
| Decided | 2026-07-31 |
| Panel / class | Orthopedic |
| Sponsor location | Towson, MD |
| Peer records CSV (9 MD records) | 🔒 Click to unlock → |
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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: 2026-07-31
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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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: Dt Medtech, LLC and 9 Maryland peers
- Maryland FdaApprovalPulse records like this one: 9
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Maryland peer: $1,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Score
What is the FdaApprovalPulse record for Dt Medtech, LLC in Towson, Maryland?
The FDA approved Hintermann Series H3 Total Ankle Replacement System (P160036 S008) for Dt Medtech, LLC on 2026-07-31: PMA supplement (device change).
How does Dt Medtech, LLC compare to other Maryland FdaApprovalPulse records?
It is 97 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.
Dt Medtech, LLC vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Dt Medtech, LLC | Towson, MD | 2026-07-31 |
| 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.