ISOTIS ORTHOBIOLOGICS, INC

FDA Device Registration & Listing · IRVINE, CA, US · Registration 2090010

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2090010
FEI Number
3001503333
Entity Name
ISOTIS ORTHOBIOLOGICS, INC
City/State/Country
IRVINE, CA, US
Establishment Address
2 Goodyear, IRVINE, CA 92618, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
SeaSpine Orthopedics Corporation (Owner Number: 10049589)
Owner / Operator Contact Address
5770 Armada Dr, Carlsbad, CA 92008, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K070751
PMA Number
N/A

All Registered Proprietary Names

OrthoBlast II Paste OrthoBlast II Putty Trel-XC Paste Trel-XC Putty OsteoSparx C Paste OsteoSparx C Putty AlloSync CB DBM AlloSync CB DBM Paste AlloSync CB DBM Putty OrthoBlast II DBM Putty OrthoBlast II DBM Paste DynaBlast Putty DynaBlast Paste OsteoSurge 300 Accell Evo3 (formerly (A2) OsteoSurge 100 Accell Connexus Accell TBM Accell Connexus OsteoSurge 100 Cove Putty OsteoCove Putty OsteoBallast Ballast OsteoBallast MT Ballast MT OsteoSurge 100 Accell Connexus OsteoSparx Gel OsteoSparx Putty DynaGraft II Putty DynaGraft II Gel Trel-X Putty Trel-X Gel AlloSync DBM AlloSync DBM Gel AlloSync DBM Putty Cove Strip OsteoCove Strip OsteoSurge 300C Accell Evo3C Cove Strip OsteoCove Strip DynaGraft D Gel DynaGraft D Putty IsoTis Mozaik Strip OsteoStrux Strip Orthofix Collage Strip Arthrex BoneSync Strip Accell Evo3 (formerly A2) OsteoSurge 300 OsteoStrux Putty IsoTis Mozaik Putty Orthofix Collage Osteoconductive Scaffold Putty (Orthofix Collage Putty) Orthofix Collage Putty Arthrex BoneSync Putty Torrent OsteoTorrent Torrent C OsteoTorrent C Current, OsteoCurrent OsteoBallast Ballast OsteoSparx C Paste Trel-XC Putty OrthoBlast II Putty OsteoSparx C Putty OrthoBlast II Paste Trel-XC Paste AlloSync CB DBM Putty AlloSync CB DBM AlloSync CB DBM Paste

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2015-06-24
MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Orthopedic Class 2 888.3045 2015-06-24
NUN Bone Grafting Material, Human Source Dental Class 2 872.3930 2015-06-24
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2015-06-24
MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Orthopedic Class 2 888.3045 2015-06-24
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2026-02-24
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2023-09-15
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2020-05-07
MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Orthopedic Class 2 888.3045 2020-05-07
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2020-07-06
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2015-06-24
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2015-06-24
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2023-09-28
MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Orthopedic Class 2 888.3045 2015-06-24
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2015-06-24
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2023-08-22
NUN Bone Grafting Material, Human Source Dental Class 2 872.3930 2015-06-24
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2015-06-24
MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Orthopedic Class 2 888.3045 2015-06-24
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2015-06-24
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2015-06-24
MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Orthopedic Class 2 888.3045 2021-12-03
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2021-12-03
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2019-04-22
MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Orthopedic Class 2 888.3045 2017-12-07
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2017-12-07
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2015-06-24
MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Orthopedic Class 2 888.3045 2015-06-24

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SeaSpine Orthopedics Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3012120772 SEASPINE ORTHOPEDICS CORPORATION Carlsbad, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K180121 Cellumed Co., Ltd. Rafugen DBM 2018-04-11
K062691 Takiron Co., Ltd. COMPORUS 2008-04-15
K023703 Berkeley Advanced Biomaterials, Inc. BI-OSTETIC 2003-01-30
K173933 Xenco Medical, LLC Sorrento Bioglass Bone Graft Substitute 2018-09-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2090010. Last updated year: 2026. Please use registration number 2090010 when referencing this establishment in official correspondence.
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