Manufacturer registered with FDA
DePuy Spine, Inc.
Raynham, MA, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 7
- 510(k) clearances
- 22008–2010
- Markets registered in
- 669 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Registered in 6 markets
Where regulators' registries name DePuy Spine, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | DePuy Spine, Inc. | 2 clearances | 2008–2010 | Below |
| Taiwan | TFDA | Manufacturer | DEPUY SPINE, INC. | 22 | 1997–2021 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | DEPUY SPINE, INC.DEPUY SPINE INC. | 19 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DEPUY SPINE, INC. | 16 | 2004–2022 | Pure Global AI |
| Israel | AMAR | Manufacturer | DePuy Spine, Inc. | 6 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | DEPUY SPINE, INCDEPUY SPINE · DEPUY SPINE, Inc. | 6 | 2018–2024 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What DePuy Spine, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Synthetic Bone Grafting MaterialLYC · Class 2 | Bone grafts & membranes | Maker | HEALOS DentalHEALOS Dental Bone Graft ReplacementHealos II Bone Graft SubstituteSymphonySYMPHONY GRAFT DELIVERY SYSTEM | 2008 |
| Animal Source Bone Grafting MaterialNPM · Class 2 | Bone grafts & membranes | Maker | HEALOS DentalHEALOS Dental Bone Graft Replacement | 2008 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names DePuy Spine, Inc. as the applicant.
Also lists devices cleared under other names
DePuy Spine, Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Depuyacromed (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 1 Mar 2001 | K010320 | MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM | Depuyacromed | LYC Synthetic Bone Grafting Material |
| 18 Jan 2001 | K003286 | SYMPHONY GRAFT DELIVERY SYSTEM | Depuyacromed | LYC Synthetic Bone Grafting Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DEPUY SPINE, INC.FDA reg. 1526439 | RAYNHAM, MA, United States | Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1526439). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.