Manufacturer registered with FDA
SeaSpine Orthopedics Corporation
Carlsbad, CA, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 7
- 510(k) clearances
- 22004–2005
- Markets registered in
- 1085 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Registered in 10 markets
Where regulators' registries name SeaSpine Orthopedics Corporation 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 | SeaSpine Orthopedics Corporation | 2 clearances | 2004–2005 | Below |
| Saudi Arabia | SFDA | Manufacturer | IsoTis OrthoBiologics, Inc.SeaSpine Orthopedics Corporation · IsoTis OrthoBiologics Inc | 23 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | ISOTIS ORTHOBIOLOGICS, INC. | 22 | 1999–2010 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SEASPINE ORTHOPEDICS CORPORATION | 12 | 2010–2021 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | SEASPINE ORTHOPEDICS CORPORATIONISOTIS ORTHOBIOLOGICS INC. | 11 | — | Pure Global AI |
| Australia | TGA | Manufacturer | SeaSpine Orthopedics Corporation | 5 | 2016–2023 | Pure Global AI |
| South Korea | MFDS | Manufacturer | IsoTis OrthoBiologics, Inc.ISOTIS Orthobiologics, Inc · Seaspine Orthopedics Corporation | 4 | 2004–2018 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | SeaSpine Orthopedics CorporationISOTIS Orthobiologics, Inc. | 3 | 2025–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | SeaSpine Orthopedics CorporationISOTIS ORTHOBIOLOGICS INC. | 3 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | IsoTis OrthoBiologics, Inc. | 2 | 2018–2018 | 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 SeaSpine Orthopedics Corporation currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Human Source Bone Grafting MaterialNUN · Class 2 | Bone grafts & membranes | Maker | Accell Connexus Keystone DentalDynaBlast PasteDynaBlast PuttyDynaGraft D GelDynaGraft D PuttyOrthoBlast II DBM PasteOrthoBlast II DBM Putty | 2015 |
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 SeaSpine Orthopedics Corporation as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 29 Jul 2005 | K043573 | DYNAGRAFT II DENTAL | NUN Human Source Bone Grafting Material |
| 20 Oct 2004 | K042706 | OSSATURA DENTAL | LYC Synthetic Bone Grafting Material |
Some of these clearances are listed with FDA today by another company: Keystone Dental Inc. (1).
Also lists devices cleared under other names
SeaSpine Orthopedics Corporation 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: Isotis NV (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ISOTIS ORTHOBIOLOGICS, INCFDA reg. 2090010 | IRVINE, CA, United States | Contract manufacturer, Manufacturer |
Other names on FDA records
IsoTis OrthoBiologics, Inc.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10049589). 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.