Cross Medical Products, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Cross Medical Products, Inc.” (first 1990, latest 1998), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 148 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 |
|---|---|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 3 | 3 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 2 | 2 |
| HWJ | Awl | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
Review panels
- Orthopedic (7)
Most recent Cross Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K974749 | SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR AND POSTERIOR SPINAL SYSTEMS | MNH | 1998-03-13 | 84 |
| K973836 | SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR SPINAL SYSTEM | MNH | 1998-03-05 | 148 |
| K950709 | SYNERGY TI ANTERIOR SPINAL SYSTEM | KWQ | 1995-10-25 | 254 |
| K940631 | CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEM | MNH | 1995-07-13 | 514 |
| K924381 | PWB LUMBAR LAMINAR HOOKS WITH SET SCREWS | KWP | 1993-05-18 | 260 |
| K920116 | PWB LUMBOSACRAL SPINE SYSTEM | KWP | 1992-04-10 | 88 |
| K895587 | CROSS MEDICAL PRODUCT PEDICLE AWL | HWJ | 1990-01-04 | 111 |
Recalls
openFDA lists no recalls under a recalling firm named Cross Medical Products, 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.
- Cross Country Paper Products Corp. (3 510(k)s)
- Cross Vascular, Inc. (2 510(k)s)
- Cross Protection (M) Sdn Bhd (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cross Medical Products, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Cross Medical Products, Inc.” (first 1990, latest 1998), across 4 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 Cross Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cross Medical Products, Inc. is 148 days.
Which FDA product codes appear under Cross Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are MNH (Orthosis, Spondylolisthesis Spinal Fixation, 3); KWP (Appliance, Fixation, Spinal Interlaminal, 2); HWJ (Awl, 1).
Next steps
- See all 7 Cross Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MNH, Cross Medical Products, 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.