510(k) K142587
- Device
- Vertical Expandable Prosthetic Titanium Rib
- Applicant
- Depuy Synthes Spine, Inc.
- 510(k) number
- K142587
- Product code
- MDI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-11-18
- Date received
- 2014-09-15
- Regulation
- 510(k) Premarket Notification
- Classification name
- Prosthesis, Rib Replacement
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Catherine Kilshaw
- Address
- 325 Paramount Dr. Raynham MA US 02767 02767
FDA Registration Numbers#
- 3008812560
- 3015212339
- 3008868758
- 3006460162
- 3009417901
Source Documents#
Other 510(k) Records For Product Code MDI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233105 | RESPONSE™ Rib and Pelvic System | OrthoPediatrics Corp. | 2024-01-20 |
Legacy Summary#
summary
FDA Review#
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