Data / Medical devices / France / Science & Bio Materials, S.B.M. SAS
Science & Bio Materials, S.B.M. SAS: FDA-registered device maker in LOURDES Hautes-Pyrenees, France, 12 510(k) clearances
Science & Bio Materials, S.B.M. SAS is registered with the FDA (registration 3004549189) in LOURDES Hautes-Pyrenees, France. It lists 12 device types. The FDA files 12 510(k) clearances under its listings, the newest dated June 2, 2025. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004549189
- FEI number
- 3004051158
- Address
- Zi Du Monge, LOURDES Hautes-Pyrenees, France, 65100
- Owner or operator
- SCIENCE & BIO MATERIALS (9063735)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- March 6, 2006
- Registered through
- 2026
- Brand names listed
- 250 X 250 sterilization basket lid, Catalog Number PULLIGPA04, 250 x 250 sterilization basket with silicone mat, Catalog Number PULLIGPA03, BIO 1 Block for filling - 10x10x25 mm (2,5 cm3), Catalog Number P822694444, BIO 1 Block for filling - 10x10x25 mm (5 cm3), Catalog Number P822694446, BIO 1 Cubes for filling - 10 x 10 x 10 mm (1 cm3), Catalog Number P822693620, BIO 1 Cubes for filling - 10 x 10 x 10 mm (10 cm3), Catalog Number P822693624, BIO 1 Cubes for filling - 10 x 10 x 10 mm (15 cm3), Catalog Number P822693626, BIO 1 Cubes for filling - 10 x 10 x 10 mm (2 cm3), Catalog Number P822693622 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bit, Drill | HTW | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Cutter, Wire | HXZ | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Filler, Bone Void, Calcium Compound | MQV | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 2, 2025 | K250844 | PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP T; RIGIDLOOP Clip; RIGIDLOOP BTB; RIGIDLOOP Suture Loop | MBI | Substantially Equivalent | Science & Bio Materials (S.B.M.) Sas | accessdata.fda.gov |
| August 3, 2023 | K223122 | MENIX®; MENIX® DUO | GAT | Substantially Equivalent | S.B.M. Sas (Science & Bio Materials) | accessdata.fda.gov |
| July 26, 2023 | K231787 | ecoFIX® | MAI | Substantially Equivalent | Science & Bio Materials (S.B.M.) Sas | accessdata.fda.gov |
| October 16, 2020 | K202193 | PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction | MBI | Substantially Equivalent | S.B.M. Sas (Science & Bio Materials) | accessdata.fda.gov |
| July 25, 2018 | K180960 | FIXIT / ComposiTCP Threaded Anchor System | MAI | Substantially Equivalent | S.B.M. Sas Sciences For Bio Materials | accessdata.fda.gov |
| November 30, 2017 | K170868 | FIXIT Threaded Anchor System | MAI | Substantially Equivalent | S.B.M Sas Science For Bio Materials | accessdata.fda.gov |
| November 17, 2015 | K151004 | PULLUP® Adjustable Juxtacortical Fixation Device | MBI | Substantially Equivalent | Sbm Sciences For Bio Materials | accessdata.fda.gov |
| October 3, 2012 | K122228 | LIGAFIX INTERFERENCE SCREW | MAI | Substantially Equivalent | Sbm Sciences For Bio Materials | accessdata.fda.gov |
| April 19, 2012 | K120818 | OTIS-C PLUS | HRS | Substantially Equivalent | Science For Biomaterials | accessdata.fda.gov |
| July 3, 2007 | K071155 | MODIFICATION TO: BIOSORB RESORBABLE VOID FILLER | MQV | Substantially Equivalent | Science For Biomaterials | accessdata.fda.gov |
| July 5, 2006 | K061262 | LIGAFIX INTERFERENCE SCREW | HWC | Substantially Equivalent | Sciences For Bio Materials | accessdata.fda.gov |
| January 28, 2003 | K021963 | BIOSORB RESORBABLE VOID FILLER | MQV | Substantially Equivalent | Sciences ET Bio Materiaux (Sbm) | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 7, 2025 | 96632 | Class II | Ongoing | Bio 1 Granules for Filling 1 mm (2 cm), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity) | Vials of implant bone granules may contain less product then specified on labeling. | accessdata.fda.gov |
| October 7, 2021 | 90281 | Class II | Completed | ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605 | Mislabeled product. | accessdata.fda.gov |
Compare with other makers
- All makers of Screw, Fixation, Bone
- All makers of Filler, Bone Void, Calcium Compound
- All makers of Cutter, Wire
- All makers of Suture, Nonabsorbable, Synthetic, Polyethylene
- All makers of Tap, Bone
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
Updated June 2, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.