Hall Surgical, Division of Zimmer, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Hall Surgical, Division of Zimmer, Inc.” (first 1985, latest 1994), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 42 days. 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
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRX | Arthroscope | 2 | 2 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 2 | 2 |
| DWH | Blade, Saw, Surgical, Cardiovascular | 1 | 1 |
| DZE | Implant, Endosseous, Root-Form | 1 | 1 |
| GBX | Catheter, Irrigation | 1 | 1 |
| HTT | Burr, Orthopedic | 1 | 1 |
Review panels
- Orthopedic (5)
- General and Plastic Surgery (2)
- Dental (1)
Most recent Hall Surgical, Division of Zimmer, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K942660 | HALL MICROCHOICE ELECTRIC POWERED SYSTEM | HWE | 1994-09-07 | 93 |
| K864734 | HALL ORAL IMPLANT SYSTEM | DZE | 1987-02-10 | 68 |
| K864929 | HALL (R) MICRO E POWERED SURGICAL INSTRUMENT SYST | HWE | 1987-01-28 | 43 |
| K864163 | HALL DUNBAR DRILL GUIDE SYSTEM | HRX | 1986-11-20 | 28 |
| K862778 | HALL CANNLULA SYSTEM | HRX | 1986-09-08 | 48 |
| K862474 | HALL STERNUM SAW | DWH | 1986-07-17 | 17 |
| K862529 | HALL STERILE BUR | HTT | 1986-07-15 | 13 |
| K852143 | HALL IRRIGATION SYSTEM | GBX | 1985-06-26 | 41 |
Recalls
openFDA lists no recalls under a recalling firm named Hall Surgical, Division of Zimmer, 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.
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.
- Hall Laboratories, Inc. (2 510(k)s)
- Hall Medical Laboratories (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hall Surgical, Division of Zimmer, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Hall Surgical, Division of Zimmer, Inc.” (first 1985, latest 1994), across 6 product codes in 3 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 Hall Surgical, Division of Zimmer, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hall Surgical, Division of Zimmer, Inc. is 42 days.
Which FDA product codes appear under Hall Surgical, Division of Zimmer, Inc.?
The most frequent FDA product codes under this applicant name are HRX (Arthroscope, 2); HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment, 2); DWH (Blade, Saw, Surgical, Cardiovascular, 1).
Next steps
- See all 8 Hall Surgical, Division of Zimmer, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRX, Hall Surgical, Division of Zimmer, 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.