Si-Bone Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000028624 FEI 3007700286
Si-Bone Inc. is a medical device manufacturer based in the United States, with 825 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II and I; EU Class I and IIa) and 1 FDA recall as of 12 Nov 2026.
- Devices
- 825
- Registrations
- EUDAMEDFDA
- FDA recalls
- 11 ongoing
Registry facts
- Registries
- FDA GUDID 781
- EUDAMED 335
- FDA 510(k) 21
- Device classes
- FDA Class II 413
- FDA Class I 186
- EU Class I 165
- EU Class IIa 61
- Top EMDN categories
- Orthopaedic and traumatological surgery instruments, reusable 133
- Orthopaedic prostheses, osteosynthesis devices, devices for tendon and ligament synthesis 59
- Surgical instruments, reusable - various accessories 14
- Instruments for functional explorations and therapeutic interventions 8
- Neurosurgery and spinal surgery instruments, reusable 7
- Devices for sterilisation and packaging (excluding cat. d - z) 4
- FDA recalls
- Sites and related companies
- ICON (LR) Limited authorised representative
- Identifiers
- EUDAMED SRN US-MF-000028624
- FDA FEI 3007700286
- DUNS 830127168
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI, FDA recalls
- Authorised rep.
- ICON (LR) LimitedIE
What Si-Bone Inc. makes
Si-Bone Inc. manufactures sacroiliac joint transarticular fixation and arthrodesis implants, including coated versions, along with spinal bone screws, bone set screws, and related implantation kits. The company also produces reusable orthopaedic implantation sleeves, instrument trays, surgical drill guide obturators, and non-medicated single-use surgical procedure kits for spinal procedures.
These devices are classified as Class I and Class II medical devices and are listed in the FDA’s Unique Device Identification (FDA UDI) system. Si-Bone Inc. is based in the United States.
Catalogue
Search and filter all 825 devicesShowing 1-50 of 825
Company details
- EUDAMED SRN
- US-MF-000028624
- SRN (system / procedure pack)
- US-PR-000044785
- FDA FEI number
- 3007700286
- DUNS number
- 830127168
- EUDAMED status
- Active
- EUDAMED registered name
- SI-BONE, Inc.
- EUDAMED abbreviated name
- SI-BONE
- Registered address
- 88, W. Plumeria Drive, 95134, San Jose, California, United States
- Website
- si-bone.com/
- dcher@si-bone.com
- Phone
- 1 408 207 0700
- PRRC contact
- Daniel Cher
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 20 Dec 2028
TÜV SÜD Product Service GmbH 0123 1 certificate
- G15 131279 0001 Active
Quality management system EU MDR
- Issued
- 21 Oct 2026
- Expires
- 20 Dec 2028
- Reason
- Mnf data change
FDA recalls
FDA recall records list 1 recall initiated by Si-Bone Inc., initiated on 2026-08-21. By recorded status: 1 ongoing. The reasons filed fall into these groups: sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 1
2026
- 21 Aug 2026 Z-0146-2027 Class II Ongoing The pelvic fixation screws failed to meet acceptance criteria for tube packaging seal integrity testing; therefore, sterility assurance cannot be ensured.
Frequently asked questions
How many devices does Si-Bone Inc. have in the registry?
The registry currently lists 825 devices for Si-Bone Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Si-Bone Inc.'s devices?
Among its 50 most recently registered devices, Si-Bone Inc. has devices listed in FDA GUDID (50 devices).
What risk classes do Si-Bone Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Si-Bone Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Si-Bone Inc.?
FDA recall records list 1 recall initiated by Si-Bone Inc., the most recent initiated on 21 Aug 2026. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for Si-Bone Inc.?
EUDAMED lists 1 certificate for Si-Bone Inc. (quality management system) under MDR. The most recent was issued on 21 Oct 2026.
What are the newest devices from Si-Bone Inc. in the registry?
The most recently registered devices listed for Si-Bone Inc. include NON NAVIGATED STYLET-OBTURATOR ASSEMBLY 403005-0100, GRANITE CANNULATED PROBE SHAFT 502218, CANNULATED PROBE HANDLE ASSEMBLY 403007 and CANNULATED PROBE IMPACTION CAP ASSEMBLY 403006.