Spineart USA, Inc.: PMA approval for BAGUERA®C Cervical Disc Prosthesis
Spineart USA, Inc. (Laguna Hills, California): PMA approval for BAGUERA®C Cervical Disc Prosthesis. Dated 86 days ago, it serves as a historical benchmark. Score 55/100. 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: 109 related CA FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Spineart USA, Inc. |
| Product | BAGUERA®C Cervical Disc Prosthesis |
| Generic / ingredient | Prosthesis, intervertebral disc |
| Approval | PMA original approval (new class III device) |
| Application | P250042 |
| Decided | 2026-08-10 |
| Panel / class | Orthopedic |
| Sponsor location | Laguna Hills, CA |
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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: 2026-08-10
- 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: Spineart USA, Inc. and 110 California peers
- California FdaApprovalPulse records like this one: 110
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every California peer: $22,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Score
- A new product launch.
What is the FdaApprovalPulse record for Spineart USA, Inc. in Laguna Hills, California?
The FDA approved BAGUERA®C Cervical Disc Prosthesis (P250042) for Spineart USA, Inc. on 2026-08-10: PMA original approval (new class iii device).
How does Spineart USA, Inc. compare to other California FdaApprovalPulse records?
It is 86 days old; check the official source for later updates before acting.
Spineart USA, Inc. vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Spineart USA, Inc. | Laguna Hills, CA | 2026-08-10 |
| Edwards Lifesciences, LLC | Irvine, CA | 2026-10-01 |
| MedAlliance, LLC | Irvine, CA | 2026-09-18 |
| Freenome, LLC | Brisbane, CA | 2026-07-24 |
Related records
FdaApprovalPulse: PMA original approval (new class III device) FdaApprovalPulse: records in California
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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.