Panels › Orthopedic › Product code LOD · Class 2
Bone Cement
Regulation 888.3027
1510(k)s in 12 months (72 all time)
6recalls in 12 months (36 all time)
16recalls that name a 510(k)
Top companies in LOD
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2026 | Heraeus Medical GmbH (Dental Division) PALACOS MV pro 40; PALACOS MV pro 80. Model/Catalog Number: 5150633; 5150635.
Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitabl Open, Classified |
LOD | K213812 |
| Sep 25, 2026 | Heraeus Medical GmbH (Dental Division) PALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287.
Radiopaque, poly (methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable Open, Classified |
LOD | K210607 |
| Jan 14, 2026 | Heraeus Medical GmbH (Dental Division) Brand Name: PALACOS
Product Name: PALACOS MV pro 40; PALACOS MV pro 80
Model/Catalog Number: 5150633; 5150635
Software Version: N/A
Product Description: Radiopaque, poly(methyl methacrylate)-based (PM Open, Classified |
LOD | K213812 |
| Jan 14, 2026 | Heraeus Medical GmbH (Dental Division) Brand Name: PALACOS
Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80
Model/Catalog Number: 5081290; 5081291
Software Version: N/A
Product Description: Radiopaque, poly(methyl methacrylate)-based Open, Classified |
LOD | K210607 |
| Jan 14, 2026 | Heraeus Medical GmbH (Dental Division) Brand Name: PALACOS
Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80
Model/Catalog Number: 5081288; 5081289
Software Version: N/A
Product Description: Radiopaque, poly(methyl methacrylate)-based ( Open, Classified |
LOD | K210607 |
| Jan 14, 2026 | Heraeus Medical GmbH (Dental Division) Brand Name: PALACOS
Product Name: PALACOS R pro 40; PALACOS R pro 80
Model/Catalog Number: 5081286; 5081287
Software Version: N/A
Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA Open, Classified |
LOD | K210607 |
| Dec 20, 2022 | Howmedica Osteonics Corp. Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic
Catalog Number:6197-1-001 Open, Classified |
LOD | K014199 |
| Dec 20, 2022 | Howmedica Osteonics Corp. Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic
Catalog Number: 6191-0-001 Open, Classified |
LOD | K002652 |
| May 19, 2021 | BIOPSYBELL S.R.L. 10 GAUGE DRILL, CODE INTVM-DRL Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. 10G COAXIAL CANNULA WITH TUOHY CONNECTION, CODE INTVM-CC Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. 10G DIRECT WORKING CANNULA BEVEL TIP 15CM, CODE INTVM-DWCB/15 Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. 8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCB Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. 11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAK Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. 11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE INTVMN-DWCD Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. CEMIX - CEMENT MIXING SYSTEM, CODE INTV-MMS Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. 11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES), CODE INTVMN-SCDK Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. 8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCB Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. 10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. 10 GAUGE CEMENT DELIVERY CANNULA, CODE INTVM-CDC Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. EASYNJECT, Device for cement infusion in the vertebroplasty procedure, REF KVTGUN-DS Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. CEMENT MIXING SYSTEM, VERTEBROPLASTY-KYPHOPLASTY, REF VCF-1051 Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. RENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL1112C1-US Terminated |
LOD | None listed |
| May 19, 2021 | BIOPSYBELL S.R.L. BPB medica CEMIX, PRODUCT NUMBER KVTMIXN, Vertebroplasty-Kyphoplasty cement mixing system Terminated |
LOD | None listed |
| Dec 18, 2020 | Smith & Nephew, Inc. VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage: VERSABOND is a medium viscosity bone cement which can be used for hip, knee, and shoulder Terminated |
LOD | K022688 |
| Nov 9, 2017 | Stryker Instruments Div. of Stryker Corporation 1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01)7613252039259
Bone cement. Terminated |
LOD | K032945 |
| Nov 6, 2017 | Encore Medical, Lp Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS
Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic pro Open, Classified |
LOD | K051496 |
| Nov 6, 2017 | Encore Medical, Lp Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS
Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic pro Open, Classified |
LOD | K091608 |
| Nov 6, 2017 | Encore Medical, Lp Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS
Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee Open, Classified |
LOD | K091608 |
| Nov 6, 2017 | Encore Medical, Lp Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS
Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee Open, Classified |
LOD | K051496 |
| Apr 25, 2017 | Zimmer Biomet, Inc. Cobalt HV Bone Cement
Cobalt MV Bone Cement
Cobalt HV Bone Cement With Gentamicin Terminated |
LOD | K051496 K091908 |
| Aug 19, 2016 | Encore Medical, Lp Cobalt HV Bone Cement
Product Usage: Cobalt HV Bone Cement provides two separate, pre-measured and sterilized components which when mixed form a radiopaque, rapidly setting bone cement. Terminated |
LOD | K051496 |
| Dec 31, 2014 | Zimmer, Inc. Osteobond Bone Cement
Bone cement monomer is kitted with bone cement powder to create a cement mantle for orthopedic implants. Terminated |
LOD | None listed |
| Feb 5, 2003 | Biomet Inc Palacos R radiopaque bone cement, 40 gram. Product number 424800. Terminated |
LOD | None listed |
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