Opteform® Allograft Disc, 45mm X 5mm, 8cc
Catalogue number 002545, listed by Rti Surgical, Inc., United States, under Filler, Bone Void, Calcium Compound. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Allgens Medical Technology Co., Ltd. | Beijing | Beijing | Complaint-file establishment | 1 |
Record
| Listed by | Rti Surgical, Inc., United States |
|---|---|
| FDA product code | MQV |
| Device type | Filler, Bone Void, Calcium Compound |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3045 |
| 510(k) | K043421 |
| Record published | 2015-11-06 |
| Record revised | 2023-10-19 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature -40 to -20 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 002545 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Synthacer | medArtis Medizinprodukte und Forschung Aktiengesellschaft | 360 |
| Syntricer | medArtis Medizinprodukte und Forschung Aktiengesellschaft | 357 |
| Biosorb | S.B.M | 65 |
| MagnetOs | Kuros Biosciences B.V | 61 |
| BioSet® | Rti Surgical, Inc. | 47 |
| Bicera® Resorbable Bone Substitute | Wiltrom Corporation Limited | 41 |
| GRAFTON®and Grafton PLUS®Demineralized Bone Matrix (DBM) | Medtronic Sofamor Danek, Inc. | 40 |
| Bicera® Resorbable Bone Substitute | Wiltrom Co., Ltd. (Chutung) | 39 |
| ChronOS | Synthes Gmbh | 39 |
| Synthacer/Syntricer | medArtis Medizinprodukte und Forschung Aktiengesellschaft | 36 |
| Inion BioRestore™ | Inion OY | 35 |
| Resorba Synthetic Bone | Biomatlante | 35 |
Showing 12 of 750. All products under Filler, Bone Void, Calcium Compound
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241555 | 2025-02-21 |
Recalls Naming This Product
13 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Exactech, Inc. | 510(k) number | 2019-04-26 | Class II | Environmental control | The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment. | 2 units | 2021-04-22 |
| Exactech, Inc. | 510(k) number | 2019-04-26 | Class II | Environmental control | The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment. | 2 units | 2021-04-22 |
| Exactech, Inc. | 510(k) number | 2019-04-26 | Class II | Environmental control | The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment. | 3 units | 2021-04-22 |
| RTI Surgical, Inc. (dba RTI Biologics, Inc.) | 510(k) number | 2017-01-23 | Class II | Labeling Change Control | Incorrect instructions for use (IFU) included. | 24 units | 2018-04-05 |
| RTI Surgical, Inc. (dba RTI Biologics, Inc.) | 510(k) number | 2013-12-06 | Class II | Other | RTI Surgical, Inc. of Alachua, FL is recalling their OPTEFORM Allograft Paste, 5cc as it may contain a 10 cc fluid dispenser. The 10cc fluid dispenser does not include the correct fluid fill line reference for reconstitution of 5cc past all | 14 units | 2014-09-15 |
| RTI Surgical, Inc. (dba RTI Biologics, Inc.) | 510(k) number | 2005-10-14 | Not classified | Other | The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processin | 2012-07-26 | |
| RTI Surgical, Inc. (dba RTI Biologics, Inc.) | 510(k) number | 2005-10-14 | Not classified | Other | The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processin | 2012-07-26 | |
| RTI Surgical, Inc. (dba RTI Biologics, Inc.) | 510(k) number | 2005-10-14 | Not classified | Other | The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processin | 2012-07-26 | |
| RTI Surgical, Inc. (dba RTI Biologics, Inc.) | 510(k) number | 2005-10-14 | Not classified | Other | The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processin | 2012-07-26 | |
| RTI Surgical, Inc. (dba RTI Biologics, Inc.) | 510(k) number | 2005-10-14 | Not classified | Other | The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processin | 2012-07-26 | |
| RTI Surgical, Inc. (dba RTI Biologics, Inc.) | 510(k) number | 2005-10-14 | Not classified | Other | The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processin | 2012-07-26 | |
| RTI Surgical, Inc. (dba RTI Biologics, Inc.) | 510(k) number | 2005-10-14 | Not classified | Other | The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processin | 2012-07-26 | |
| RTI Surgical, Inc. (dba RTI Biologics, Inc.) | 510(k) number | 2005-10-14 | Not classified | Other | The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processin | 2012-07-26 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.