Orthocon, Inc.
Colts Neck, NY, US
Orthocon, Inc. appears in FDA device records in Colts Neck, NY. FDA records list 39 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 39
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 39 510(k) clearances for Orthocon, Inc. between 2005 and 2026. The busiest year on record is 2023, with 8. The most recent is 2026, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2009 | 1 |
| 2011 | 1 |
| 2012 | 3 |
| 2013 | 2 |
| 2014 | 4 |
| 2015 | 1 |
| 2016 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 8 |
| 2024 | 6 |
| 2026 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261265 | Permatage XT Settable Bone Putty | GXP | Substantially Equivalent | |
| K261439 | Permatage Flowable, Settable Hemostatic Bone Paste | MTJ | Substantially Equivalent | |
| K253447 | Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) | GXR | Substantially Equivalent | |
| K253732 | Permatage Flowable, Settable Bone Paste | GXP | Substantially Equivalent | |
| K253854 | MONTAGE XT Cranial Cement | GXP | Substantially Equivalent | |
| K243526 | MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty | MQV | Substantially Equivalent | |
| K243506 | Montage-XT Settable Bone Putty | MQV | Substantially Equivalent | |
| K241027 | Permatage Settable Bone Putty | GXP | Substantially Equivalent | |
| K233566 | Montage-XT Settable, Resorbable Bone Putty | MQV | Substantially Equivalent | |
| K242050 | Montage Settable Bone Putty | MQV | Substantially Equivalent | |
| K232771 | Montage Flowable Settable, Resorbable Bone Paste | GXP | Substantially Equivalent | |
| K232998 | Montage- XT Settable, Resorbable Hemostatic Bone Putty | MTJ | Substantially Equivalent | |
| K231475 | MONTAGE-QS Settable, Resorbable Bone Putty | GXP | Substantially Equivalent | |
| K231270 | Montage Flowable Settable, Resorbable Bone Paste | MQV | Substantially Equivalent | |
| K213418 | MONTAGE Settable, Resorbable Hemostatic Bone Putty | MTJ | Substantially Equivalent | |
| K231903 | Montage-QS Settable, Resorbable Bone Putty | MQV | Substantially Equivalent | |
| K231386 | Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste | MTJ | Substantially Equivalent | |
| K222063 | MONTAGE Settable, Resorbable Bone Putty | MQV | Substantially Equivalent | |
| K221933 | MONTAGE Settable, Resorbable Bone Putty | GXP | Substantially Equivalent | |
| K220315 | MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty | MTJ | Substantially Equivalent | |
| K202363 | HBP7 Settable Hemostatic Bone Putty | MTJ | Substantially Equivalent | |
| K193052 | HBP6 Settable, Resorbable Hemostatic Bone Paste | MTJ | Substantially Equivalent | |
| K191140 | MONTAGE-QS Settable, Resorbable Hemostatic Bone | MTJ | Substantially Equivalent | |
| K153317 | HEMASORBPLUS Resorbable Hemostatic Bone Putty | MTJ | Substantially Equivalent | |
| K152005 | MONTAGE Settable, Resorbable Hemostatic Bone Putty | MTJ | Substantially Equivalent | |
| K143069 | HEMASORBPLUS press Resorable Hemostatic Bone Putty | MTJ | Substantially Equivalent | |
| K141502 | HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY | MTJ | Substantially Equivalent | |
| K142339 | HEMASORB Resorbable Hemostatic Bone Putty | MTJ | Substantially Equivalent | |
| K140117 | AHBPPRESS ABSORBABLE HEMOSTATIC BONE PUTTY | MTJ | Substantially Equivalent | |
| K123243 | HEMASORB BONE PUTTY 3 RESORBABLE HEMOSTATIC BONE PUTTY | MTJ | Substantially Equivalent | |
| K122156 | ORTHOCON ABSORBABLE HEMOSTATIC BONE PUTTY | MTJ | Substantially Equivalent | |
| K121953 | HEMASORB APPLY | MTJ | Substantially Equivalent | |
| K111575 | HEMASORB ABSORBABLE BONE HEMOSTAT MATRIX | MTJ | Substantially Equivalent | |
| K113627 | HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY | MTJ | Substantially Equivalent | |
| K102762 | ORTHOSTAT BONE HEMOSTAT MATRIX APPLICATOR | MTJ | Substantially Equivalent | |
| K091121 | ORTHOSTAT | MTJ | Substantially Equivalent | |
| K061131 | DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY | MBP | Substantially Equivalent | |
| K063330 | ORTHOCON HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY | MTJ | Substantially Equivalent | |
| K043260 | ORTHOCON LLC ORTHOSTAT HEMOSTATIC BONE PUTTY | MTJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain