Depuy Mitek, A Johnson & Johnson Company: FDA filings under this applicant name

FDA lists 62 510(k) clearances under 3 spellings of the applicant name “Depuy Mitek, A Johnson & Johnson Company” (first 2004, latest 2015), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 80 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

Caduvo groups this applicant name under Johnson & Johnson MedTech, based on public ownership records.

510(k) clearances per year

Top product codes

Review panels

• Orthopedic (53)
• General and Plastic Surgery (9)

Most recent Depuy Mitek, A Johnson & Johnson Company 510(k) clearances

52 earlier clearances. See the full list in Caduvo.

Recalls

4 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2006-02-17.

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.

FDA spellings included

FDA records this applicant under 3 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:

• Depuy Mitek, A Johnson & Johnson Company (58)
• Depuy Mitek, A Johnson and Johnson Company (3)
• Depuy Mitek, A Johnson & Johnson Co. (1)

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.

• Depuy, Inc. (303 510(k)s)
• DePuy Orthopaedics, Inc. (210 510(k)s)
• Depuy Spine, Inc. (71 510(k)s)
• Depuy Ireland UC (50 510(k)s)
• DePuy Synthes (20 510(k)s)
• Depuy Mitek (15 510(k)s)
• Depuy(Ireland) (13 510(k)s)
• Depuy Ace Medical Co. (10 510(k)s)
• Depuy Motech Acromed (4 510(k)s)
• Depuy Spine, A Johnson & Johnson Company (4 510(k)s)
• Depuy Mitek, Inc., A Johnson and Johnson Company (3 510(k)s)
• Depuy-Raynham (3 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Depuy Mitek, A Johnson & Johnson Company?

FDA lists 62 510(k) clearances under 3 spellings of the applicant name “Depuy Mitek, A Johnson & Johnson Company” (first 2004, latest 2015), across 8 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Depuy Mitek, A Johnson & Johnson Company?

The median time from FDA receipt to decision across 510(k)s cleared under the name Depuy Mitek, A Johnson & Johnson Company is 80 days.

Which FDA product codes appear under Depuy Mitek, A Johnson & Johnson Company?

The most frequent FDA product codes under this applicant name are MAI (Fastener, Fixation, Biodegradable, Soft Tissue, 20); HWC (Screw, Fixation, Bone, 13); MBI (Fastener, Fixation, Nondegradable, Soft Tissue, 8).

Next steps

• See all 62 Depuy Mitek, A Johnson & Johnson Company clearances with predicates and recalls
• Run predicate analysis for product code MAI, Depuy Mitek, A Johnson & Johnson Company'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 (spelling variants such as punctuation and legal suffixes combined); 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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