510(k) K052528
- Device
- AOC BONE WAX OSTENE, OSTEOTENE AND CERETENE
- Applicant
- CEREMED, INC.
- 510(k) number
- K052528
- Product code
- MTJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-10-11
- Date received
- 2005-09-14
- Regulation
- 510(k) Premarket Notification
- Classification name
- Wax, Bone
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- General & Plastic Surgery
- Device class
- U
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TADEUSZ WELLISZ
- Address
- 3643 Lenawee Ave. Los Angeles CA US 90016 90016
FDA Registration Numbers#
- 3039667438
- 3002807315
- 2029275
- 3007791599
- 2024024
- 3006981798
- 3030733800
- 3007205024
- 1043214
- 2320762
- 3008812560
- 1450662
- 2210968
- 1423662
- 3004450973
- 3017102971
- 1055236
- 3002807314
- 3030446844
- 3005972619
- 1416980
- 3010692967
- 2953359
- 3018094310
- 3011137372
- 1037598
- 1000512200
- 1054241
- 2245304
- 2032098
- 3004903580
- 3013644499
- 3012026312
Source Documents#
Other 510(k) Records For Product Code MTJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232998 | Montage- XT Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2023-10-12 |
| K213418 | MONTAGE Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2023-08-30 |
| K231386 | Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste | Orthocon, Inc. | 2023-07-11 |
| K200452 | Meril-Bonewax | M/s. Meril Endo Surgery Private Limited. | 2023-03-27 |
| K220315 | MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2022-03-11 |
| K202363 | HBP7 Settable Hemostatic Bone Putty | Orthocon, Inc. | 2021-01-19 |
| K193052 | HBP6 Settable, Resorbable Hemostatic Bone Paste | Orthocon, Inc. | 2020-03-27 |
| K191140 | MONTAGE-QS Settable, Resorbable Hemostatic Bone | Orthocon, Inc. | 2019-07-18 |
| K153317 | HEMASORBPLUS Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2016-11-30 |
| K153095 | ROP Resorbable Hemostasis Material | Resorbable Orthopedic Products, LLC | 2016-02-17 |
| K152005 | MONTAGE Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2015-10-15 |
| K142348 | OsteoSeal Bone Hemostat | Hemostasis, LLC | 2015-01-23 |
| K143069 | HEMASORBPLUS press Resorable Hemostatic Bone Putty | Orthocon, Inc. | 2014-12-22 |
| K141502 | HBP4 HARDENING, RESORBABLE HEMOSTATIC BONE PUTTY | Orthocon, Inc. | 2014-10-03 |
| K142339 | HEMASORB Resorbable Hemostatic Bone Putty | Orthocon, LLC | 2014-09-26 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases