Custom Orthopaedic Solutions, Inc.: FDA filings under this applicant name

FDA lists 8 510(k) clearances under 2 spellings of the applicant name “Custom Orthopaedic Solutions, Inc.” (first 2013, latest 2017), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 113 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

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Custom Orthopaedic Solutions, Inc. took a median 136 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 127 days.

Top product codes

Review panels

• Orthopedic (4)
• Radiology (4)

Most recent Custom Orthopaedic Solutions, Inc. 510(k) clearances

Recalls

openFDA lists no recalls under a recalling firm named Custom Orthopaedic Solutions, 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.

FDA spellings included

FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:

• Custom Orthopaedic Solutions, Inc. (6)
• Custom Orthopaedic Solutions (2)

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.

• Custom Pack Reliability (21 510(k)s)
• Custom Spine, Inc. (14 510(k)s)
• Custom Medical Products, Ltd. (13 510(k)s)
• Custom Services Intl., Inc. (9 510(k)s)
• Custom Ultrasonics (6 510(k)s)
• Custom Optical Frames, Inc. (4 510(k)s)
• Custom Surgical Products, Inc. (4 510(k)s)
• Custom Medical, Inc. (3 510(k)s)
• Custom Medical Devices Intl., Inc. (3 510(k)s)
• Custom Cardio Components (2 510(k)s)
• Custom Medical Plastics, Inc. (2 510(k)s)
• Custom Assemblies, Inc. (1 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Custom Orthopaedic Solutions, Inc.?

FDA lists 8 510(k) clearances under 2 spellings of the applicant name “Custom Orthopaedic Solutions, Inc.” (first 2013, latest 2017), across 2 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 Custom Orthopaedic Solutions, Inc.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Custom Orthopaedic Solutions, Inc. is 113 days.

Which FDA product codes appear under Custom Orthopaedic Solutions, Inc.?

The most frequent FDA product codes under this applicant name are KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented, 4); LLZ (System, Image Processing, Radiological, 4).

Next steps

• See all 8 Custom Orthopaedic Solutions, Inc. clearances with predicates and recalls
• Run predicate analysis for product code KWS, Custom Orthopaedic Solutions, 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 (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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