Terray Manufacturing, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Terray Manufacturing, Inc.” (first 1987, latest 1992), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 74 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 |
|---|---|---|---|
| FSM | Tray, Surgical, Instrument | 2 | 2 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| HWB | Extractor | 1 | 1 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| HXW | Bender | 1 | 1 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| LYQ | Accessories, Fixation, Spinal Intervertebral Body | 1 | 1 |
Review panels
Most recent Terray Manufacturing, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K910874 | THORACIC ANTERIOR SPINAL FIXATION PLATE | KWQ | 1992-02-03 | 339 |
| K882934 | CASF CANCELLOUS BONE SCREW, BT650 | HWC | 1988-10-13 | 92 |
| K882871 | CASF DRILL GUIDE DG 170 | LYQ | 1988-09-23 | 74 |
| K883193 | CASF STERILIZATION TRAY | FSM | 1988-08-10 | 13 |
| K883125 | CASF STERILIZATION TRAY | FSM | 1988-08-10 | 15 |
| K870085 | ANTERIOR SPINAL FIXATION PLATE | KWP | 1987-06-30 | 173 |
| K870082 | BONE PLATE | HRS | 1987-05-06 | 118 |
| K870083 | FERRAY EXTRACTOR | HWB | 1987-02-26 | 49 |
| K870084 | RD 140 SURGICAL BENDER | HXW | 1987-01-28 | 20 |
Recalls
openFDA lists no recalls under a recalling firm named Terray Manufacturing, 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.
- Terray Corp. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Terray Manufacturing, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Terray Manufacturing, Inc.” (first 1987, latest 1992), 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 Terray Manufacturing, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Terray Manufacturing, Inc. is 74 days.
Which FDA product codes appear under Terray Manufacturing, Inc.?
The most frequent FDA product codes under this applicant name are FSM (Tray, Surgical, Instrument, 2); HRS (Plate, Fixation, Bone, 1); HWB (Extractor, 1).
Next steps
- See all 9 Terray Manufacturing, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FSM, Terray Manufacturing, 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.