510(k) K130309
- Device
- RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM
- Applicant
- BIOMET MICROFIXATION
- 510(k) number
- K130309
- Product code
- GXR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-06-17
- Date received
- 2013-02-07
- Regulation
- 882.5250
- Classification name
- Cover, Burr Hole
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHRISTINE SCIFERT
- Address
- 3416 Roxee Run Cove Bartlett TN US 38133 38133
FDA Registration Numbers#
- 1226425
- 1218882
- 3004464325
- 3004719693
- 1032347
- 2183744
- 2027148
- 1627487
- 8043792
- 2024024
- 3004426659
- 2029447
- 2027754
- 9610612
- 3010178296
- 3011530718
- 1000606483
- 3008812560
- 3003477135
- 3004049923
- 2916714
- 1054811
- 8030965
- 3013340866
- 3007738812
- 3009417901
- 9610921
- 3015440604
- 8010177
- 3008974316
- 1721676
- 3015531529
- 1825034
- 3010155648
- 3008791302
- 9612501
- 3011423165
- 3018094310
- 3007923096
- 2011171
- 2032521
- 3017884860
- 3015399803
- 3008868758
- 1928237
- 3034676720
- 3010191069
- 2182207
- 3014937101
Source Documents#
Other 510(k) Records For Product Code GXR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253447 | Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) | Orthocon, Inc. | 2026-03-16 |
| K240137 | Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System | Neos Surgery S.L | 2024-02-16 |
| K221606 | Absorbable Cranial Flap Fixation System | Chendu Medart Medical Scientific Co., Ltd. | 2023-11-21 |
| K192310 | Flap Fixator, Burr Hole Cover | Ossaware Biotech Co., Ltd. | 2020-06-03 |
| K192162 | NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate | Neurovention, LLC | 2020-03-13 |
| K181539 | OSSDSIGN Cranioplug | Ossdsign AB | 2018-10-12 |
| K181382 | GuardianTM Burr Hole Cover System | St Jude Medical | 2018-07-20 |
| K160739 | Cranial COVER | Neos Surgery S.L | 2016-06-12 |
| K152342 | Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover | St Jude Medical | 2016-06-09 |
| K140309 | CRANIOPLUG | Ossdsign AB | 2014-10-03 |
| K141368 | NEUROPACE BURR HOLE COVER | NeuroPace, Inc. | 2014-07-11 |
| K132044 | CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM | Neos Surgery S.L | 2013-09-30 |
| K123633 | TRS CRANIAL BONE VOID FILLER(TRS C-BVF) | Tissue Regeneration Systems, Inc. | 2013-08-16 |
| K123163 | NEUROPACE BURR HOLE COVER MODEL 8110 | NeuroPace, Inc. | 2013-01-18 |
| K101235 | CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM | Neos Surgery S.L | 2010-10-25 |
Legacy Summary#
summary
FDA Review#
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