Providence Medical Technology, Inc.: FDA filings under this applicant name

FDA lists 21 510(k) clearances under the applicant name “Providence Medical Technology, Inc.” (first 2012, latest 2026), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 85 days. Since 2017 the median was 74 days, against 96 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Providence Medical Technology, Inc. took a median 74 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 96 days.

Top product codes

Review panels

• Orthopedic (21)

Most recent Providence Medical Technology, Inc. 510(k) clearances

11 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named Providence Medical Technology, Inc..

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Device clinical trials

An industry sponsor named Providence Medical Technology, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:

• NCT07222787: Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes (Recruiting, started 2025-12-01)
• NCT04229017: Study of Posterior Cervical Stabilization System (PCSS) as Part of Circumferential Fusion to Treat Multilevel DDD (Active not recruiting, started 2020-03-18)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Providence Global Medical, Inc. (2 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Providence Medical Technology, Inc.?

FDA lists 21 510(k) clearances under the applicant name “Providence Medical Technology, Inc.” (first 2012, latest 2026), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Providence Medical Technology, Inc.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Providence Medical Technology, Inc. is 85 days. Since 2017: 74 days, versus 96 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Providence Medical Technology, Inc.?

The most frequent FDA product codes under this applicant name are MRW (System, Facet Screw Spinal Device, 9); HRX (Arthroscope, 3); OLO (Orthopedic Stereotaxic Instrument, 3).

Next steps

• See all 21 Providence Medical Technology, Inc. clearances with predicates and recalls
• Run predicate analysis for product code MRW, Providence Medical Technology, Inc.'s most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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