Ortho-Space , Ltd.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Ortho-Space , Ltd.”, plus 1 De Novo 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.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QPQ | Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed | 1 | 0 |
Review panels
- Orthopedic (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN200039 | De Novo | Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed | 2021-07-12 |
Recalls
openFDA lists no recalls under a recalling firm named Ortho-Space , Ltd..
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.
- Ortho-Clinical Diagnostics, Inc. (142 510(k)s)
- Ortho Diagnostic Systems, Inc. (126 510(k)s)
- Ortho Development Corp. (64 510(k)s)
- Ortho Diagnostics, Inc. (24 510(k)s)
- Ortho Tec, LLC (22 510(k)s)
- Ortho Pharmaceutical Corp. (9 510(k)s)
- Ortho Source (9 510(k)s)
- Ortho Organizers, Inc. (8 510(k)s)
- Ortho Kinetics Corp. (7 510(k)s)
- Ortho Instruments (6 510(k)s)
- Ortho Kinematics, Inc. (6 510(k)s)
- Ortho Solutions Limited (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ortho-Space , Ltd.?
FDA lists 0 510(k) clearances under the applicant name “Ortho-Space , Ltd.”, plus 1 De Novo 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 Ortho-Space , Ltd.?
The most frequent FDA product codes under this applicant name are QPQ (Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed, 1).
Next steps
- See all 0 Ortho-Space , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code QPQ, Ortho-Space , Ltd.'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.