Methyl Methacrylate For Cranioplasty
Regulation 882.5300
4510(k)s in 12 months (45 all time)
0recalls in 12 months (30 all time)
30recalls that name a 510(k)
Top companies in GXP
| Company | 510(k)s | Recalls |
|---|---|---|
| Skeletal Kinetics, LLC | 3 | 25 |
| Orthocon, Inc. | 7 | 0 |
| Biomet, Inc. | 4 | 0 |
| Synthes (Usa) | 4 | 0 |
| Stryker Instruments | 3 | 0 |
| Doctor'S Research Group, Inc. | 1 | 1 |
| Etex Corp. | 2 | 0 |
| Osteogenics, Inc. | 2 | 0 |
| Stryker | 2 | 0 |
| Stryker Leibinger | 1 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2021 | Stryker Leibinger GmbH & Co. KG DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is moldable. The injected ceme Terminated |
GXP | K143661 |
| Apr 6, 2020 | Skeletal Kinetics, Llc CRANIOSCULPT, CMF IMPACT, 10CC,
Product Number: C-CMF10CC, UDI: 813845020955 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). T Terminated |
GXP | K162864 |
| Apr 6, 2020 | Skeletal Kinetics, Llc CRANIOSCULPT, CMF IMPACT, 5CC,
Product Number: C-CMF5CC, UDI: 813845020948 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). The Terminated |
GXP | K162864 |
| Apr 6, 2020 | Skeletal Kinetics, Llc CRANIOSCULPT, CMF IMPACT, 3CC
Product Number: C-CMF3CC, UDI: 813845020931 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). Thes Terminated |
GXP | K162864 |
| Apr 6, 2020 | Skeletal Kinetics, Llc CRANIOSCULPT FLOW, CAN, 10CC,
Product Number: C-FLOW10CC-CAN, UDI: 813845020375 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis) Terminated |
GXP | K042072 |
| Apr 6, 2020 | Skeletal Kinetics, Llc SKAFFOLD FLOW, 10CC.
Product Number: SKMX-FL10, UDI: 813845020900 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defect Terminated |
GXP | K042072 |
| Apr 6, 2020 | Skeletal Kinetics, Llc SKAFFOLD FLOW (MX) 5CC.
Product Number: SKMX-FL05, UDI: 813845020894 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These def Terminated |
GXP | K042072 |
| Apr 6, 2020 | Skeletal Kinetics, Llc SKAFFOLD FLOW, 3CC and SKAFFOLD FLOW (MX) 3CC.
Product Number: SKMX-FL03, UDI: 813845020887 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, sp Terminated |
GXP | K042072 |
| Apr 6, 2020 | Skeletal Kinetics, Llc OSTEOVATION, 5CC, IMPACT FORMULA.
Product Number: 390-2105, UDI: 813845020085 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). Terminated |
GXP | K051784 |
| Apr 6, 2020 | Skeletal Kinetics, Llc OSTEOVATION, 3CC, IMPACT FORMULA.
Product Number: 390-2103, UDI: 813845020078 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). Terminated |
GXP | K051784 |
| Apr 6, 2020 | Skeletal Kinetics, Llc OSTEOVATION, 10CC, INJECT FORMULA.
Product Number: 390-2010, UDI: 813845020061 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). Terminated |
GXP | K051784 |
| Apr 6, 2020 | Skeletal Kinetics, Llc OSTEOVATION RMX 5CC.
Product Number: 390-6001, UDI: 813845021082 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects Terminated |
GXP | K051784 |
| Apr 6, 2020 | Skeletal Kinetics, Llc OSTEOVATION RMX 10CC.
Product Number: 390-6002, UDI: 813845021099 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defect Terminated |
GXP | K051784 |
| Apr 6, 2020 | Skeletal Kinetics, Llc OSTEOVATION IMPACT 10CC and OSTEOVATION, 10CC, IMPACT FORMULA, Product Number: 390-2110,
UDI: 813845020092 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. Terminated |
GXP | K051784 |
| Apr 6, 2020 | Skeletal Kinetics, Llc CRANIOSCULPT, FLOW 5CC.
Product Number: C-FLOW5CC, UDI: 813845020337 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These def Terminated |
GXP | K042072 |
| Apr 6, 2020 | Skeletal Kinetics, Llc CRANIOSCULPT FLOW, OUS, 5CC
Product Number: C-FLOW5CC-OUS, UDI: 813845020351 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). T Terminated |
GXP | K042072 |
| Apr 6, 2020 | Skeletal Kinetics, Llc CRANIOSCULPT FLOW, OUS, 10CC.
Product Number: C-FLOW10CC-OUS, UDI: 813845020382 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis) Terminated |
GXP | K042072 |
| Apr 6, 2020 | Skeletal Kinetics, Llc CRANIOSCULPT FLOW, CAN, 5CC.
Product Number: C-FLOW5CC-CAN, UDI: 813845020344 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). Terminated |
GXP | K042072 |
| Apr 6, 2020 | Skeletal Kinetics, Llc CRANIOSCULPT FLOW, 10CC.
Product Number: C-FLOW10CC, UDI: 813845020368 - - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These Terminated |
GXP | K042072 |
| Apr 6, 2020 | Skeletal Kinetics, Llc CRANIOSCULPT FLOW, 3CC.
Product Number: C-FLOW3CC, UDI: 813845020320 - - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These d Terminated |
GXP | K042072 |
| Apr 6, 2020 | Skeletal Kinetics, Llc CRANIOSCULPT C, 5CC.
Product Number: C-C5CC, UDI: 813845021112 - - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects Terminated |
GXP | K162864 |
| Apr 6, 2020 | Skeletal Kinetics, Llc CRANIOSCULPT C, 3CC.
Product Number: C-C3CC, UDI: 813845021105 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects m Terminated |
GXP | K162864 |
| Apr 6, 2020 | Skeletal Kinetics, Llc CRANIOSCULPT C, 10CC.
Product Number: C-C10CC, UDI: 813845021129 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects Terminated |
GXP | K162864 |
| Apr 3, 2020 | Skeletal Kinetics, Llc Cranio/Sculpt C, 10cc, Bone Void Filler, UDI: 00813845021129 - Product Usage: CRANIO/SCULPT C is a calcium phosphate bone void filler indicated for the repair or filling of neurosurgical burr holes, o Terminated |
GXP | K162864 |
| Jun 6, 2019 | Skeletal Kinetics, Llc OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturing lot 1130303) - Product Usage: The product provides a bone void filler that is replaced by bone during the healing proces Terminated |
GXP | K051784 |
| Jun 6, 2019 | Skeletal Kinetics, Llc OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturing lot number 1129957) - Product Usage: The product provides a bone void filler that is replaced by bone during the healing Terminated |
GXP | K051784 |
| Aug 26, 2013 | Stryker Craniomaxillofacial Division Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (15cc), 397003 (3cc), 397005 (5cc), 397010 (10 cc), 397015 (15 cc) HydroSet Injectable HA Bone Substitute Sterile R/EO, Terminated |
GXP | K060763 |
| May 8, 2012 | Doctor's Research Group, Inc. Doctors Research Group Kryptonite Bone Cement packaged in 5cc and 10 cc Kits:
Product Codes:
KRYP-US-Z-05 (5cc Kit)
KRYP-US-Z -10 (10cc Kit)
Product Usage:
Kryptonite Bone Cement is a resinous materi Terminated |
GXP | K091382 |
| Jan 11, 2012 | OSTEOPORE INTERNATIONAL PTE LTD Osteopore PCL Scaffold Bone Filler: Osteopore Osteoplug-C, Osteoplug, and Osteomesh. Terminated |
GXP | K051093 |
| Nov 16, 2009 | Synthes USA (HQ), Inc. Norian CRS Rotary Mixer Cement 10cc sterile Terminated |
GXP | K060445 |
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