Product code GXP
- Device name
- Methyl Methacrylate For Cranioplasty
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.5300
- Review panel
- NE
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251959 | TnR Cranial Implant | T&R BIOFAB CO., Ltd. | 2026-07-30 |
| K261265 | Permatage XT Settable Bone Putty | Orthocon, Inc. | 2026-06-15 |
| K253732 | Permatage Flowable, Settable Bone Paste | Orthocon, Inc. | 2026-03-13 |
| K253854 | MONTAGE XT Cranial Cement | Orthocon, Inc. | 2026-01-02 |
| K241027 | Permatage Settable Bone Putty | Orthocon, Inc. | 2024-09-26 |
| K232771 | Montage Flowable Settable, Resorbable Bone Paste | Orthocon, Inc. | 2024-02-16 |
| K231475 | MONTAGE-QS Settable, Resorbable Bone Putty | Orthocon, Inc. | 2023-10-12 |
| K221933 | MONTAGE Settable, Resorbable Bone Putty | Orthocon, Inc. | 2023-01-13 |
| K182742 | DB-CMF | Dimensional Bioceramics, LLC | 2019-06-20 |
| K162864 | OsteoVation Impact | Skeletal Kinetics, LLC | 2017-01-13 |
| K143661 | DirectInject | Stryker | 2015-09-02 |
| K102018 | NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY | Synthes USA Products, LLC | 2010-09-23 |
| K091382 | KRYPTONITE BONE CEMENT | Doctors Research Group, Inc. | 2009-11-16 |
| K070012 | POLYBONE | Kyung Won Medical Co., Ltd. | 2007-12-27 |
| K072601 | OSTEOSYMBIONICS PATIENT SPECIFIC CRANIAL IMPLANT | Osteosymbionics, LLC | 2007-12-10 |
| K071791 | MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280 | Codman & Shurtleff, Inc. | 2007-07-30 |
| K060763 | STRYKER INJECTABLE CEMENT | Stryker | 2006-09-22 |
| K060443 | NORIAN CRS FAST SET PUTTY | Synthes (Usa) | 2006-04-13 |
| K060445 | NORIAN CRS BONE CEMENT | Synthes (Usa) | 2006-04-13 |
| K051093 | OSTEOPORE PCL SCAFFOLD | Osteopore, Inc. | 2006-03-17 |
| K051784 | OSTEOVATION CMF BONE VOID FILLER | Skeletal Kinetics, LLC | 2005-07-20 |
| K043334 | BONE SOURCE HAC RAPID SETTING CEMENT | Stryker Instruments | 2005-02-09 |
| K042414 | VISIOPLAST ACRYLIC RESIN | Tecres | 2004-12-29 |
| K043280 | MIMIX MP BONE VOID FILLER | Biomet, Inc. | 2004-12-21 |
| K042072 | CALLOS CMF BONE VOID FILLER | Skeletal Kinetics, LLC | 2004-09-16 |
| K041350 | SYNTHES (USA) CHRONOS | Synthes (Usa) | 2004-07-08 |
| K040152 | BONE CEMENT FOR CRANIOPLASTY | Cardinalhealth | 2004-05-19 |
| K032366 | BONESOURCE HAC FAST SETTING CEMENT | Stryker Instruments | 2003-10-30 |
| K032307 | CAP BONE SUBSTITUTE MATERIAL | Etex Corp. | 2003-10-24 |
| K011399 | BIOMET CRANIOFACIAL ACRYLIC CEMENT | Biomet, Inc. | 2003-05-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00813845020429 | CranioSculpt | SKELETAL KINETICS LLC | 2015-10-30 |
| 00813845020931 | CranioSculpt | SKELETAL KINETICS LLC | 2015-10-30 |
| 00813845020733 | SKaffold | SKELETAL KINETICS LLC | 2015-10-30 |
| 00813845020726 | SKaffold | SKELETAL KINETICS LLC | 2015-10-30 |
| 00813845020719 | SKaffold | SKELETAL KINETICS LLC | 2015-10-30 |
| 00813845020702 | SKaffold | SKELETAL KINETICS LLC | 2015-10-30 |
| 00813845020696 | SKaffold | SKELETAL KINETICS LLC | 2015-10-30 |
| 00813845020689 | SKaffold | SKELETAL KINETICS LLC | 2015-10-30 |
| 00813845020498 | CranioSculpt | SKELETAL KINETICS LLC | 2015-10-30 |
| 00813845020481 | CranioSculpt | SKELETAL KINETICS LLC | 2015-10-30 |
| 00813845020474 | CranioSculpt | SKELETAL KINETICS LLC | 2015-10-30 |
| 00813845020467 | CranioSculpt | SKELETAL KINETICS LLC | 2015-10-30 |
| 00813845020450 | CranioSculpt | SKELETAL KINETICS LLC | 2015-10-30 |
| 00813845020443 | CranioSculpt | SKELETAL KINETICS LLC | 2015-10-30 |
| 00813845020436 | CranioSculpt | SKELETAL KINETICS LLC | 2015-10-30 |
| 00813845020412 | CranioSculpt | SKELETAL KINETICS LLC | 2015-10-30 |
| 00813845020405 | CranioSculpt | SKELETAL KINETICS LLC | 2015-10-30 |
| 00813845020399 | CranioSculpt | SKELETAL KINETICS LLC | 2015-10-30 |
| 00813845020382 | CranioSculpt | SKELETAL KINETICS LLC | 2015-10-30 |
| 00813845020375 | CranioSculpt | SKELETAL KINETICS LLC | 2015-10-30 |
| 00813845020368 | CranioSculpt | SKELETAL KINETICS LLC | 2015-10-30 |
| 00813845020351 | CranioSculpt | SKELETAL KINETICS LLC | 2015-10-30 |
| 00813845020344 | CranioSculpt | SKELETAL KINETICS LLC | 2015-10-30 |
| 00813845020337 | CranioSculpt | SKELETAL KINETICS LLC | 2015-10-30 |
| 00813845020320 | CranioSculpt | SKELETAL KINETICS LLC | 2015-10-30 |
| 00813845020054 | OsteoVation | SKELETAL KINETICS LLC | 2015-10-22 |
| 00813845020092 | OsteoVation | SKELETAL KINETICS LLC | 2015-10-22 |
| 00813845020085 | OsteoVation | SKELETAL KINETICS LLC | 2015-10-22 |
| 00813845020078 | OsteoVation | SKELETAL KINETICS LLC | 2015-10-22 |
| 00813845020061 | OsteoVation | SKELETAL KINETICS LLC | 2015-10-22 |