Depuy, A Johnson & Johnson Co.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Depuy, A Johnson & Johnson Co.”, plus 1 PMA decision, across 1 product code in 1 review panel. 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.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | 1 | 0 |
Review panels
- Orthopedic (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P960054 | PMA | S-ROM POLY-DIAL CONSTRAINED LINER | 1997-06-19 |
Recalls
openFDA lists no recalls under a recalling firm named Depuy, A Johnson & Johnson Co..
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.
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 Mitek, A Johnson & Johnson Company (62 510(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)
Frequently asked questions
How many FDA 510(k) clearances are listed under Depuy, A Johnson & Johnson Co.?
FDA lists 0 510(k) clearances under the applicant name “Depuy, A Johnson & Johnson Co.”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Depuy, A Johnson & Johnson Co.?
The most frequent FDA product codes under this applicant name are KWZ (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, 1).
Next steps
- See all 0 Depuy, A Johnson & Johnson Co. clearances with predicates and recalls
- Run predicate analysis for product code KWZ, Depuy, A Johnson & Johnson Co.'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.