Data / Medical devices / United States / Cerapedics, Inc.
Cerapedics, Inc.: FDA-registered device maker in Westminster, CO, United States, 2 PMA approvals
Cerapedics, Inc. is registered with the FDA (registration 3007155473) in Westminster, CO, United States. It lists 2 device types. The FDA files 2 PMA approvals under its listings, the newest dated June 18, 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
- 3007155473
- Address
- 11025 Dover Street Suite 1600, Westminster, CO, United States, 80021
- Owner or operator
- Cerapedics, Inc. (10026681)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export
- First device listed
- August 11, 2008
- Registered through
- 2026
- Brand names listed
- P-15 Bone Putty, PearlMatrix Peptide Enhanced Bone Graft, i-FACTOR Bone Graft-Flex, i-FACTOR Bone Graft-Putty, i-FACTOR Flex, i-FACTOR Flex FR, i-FACTOR Peptide Enhanced Bone Graft, i-FACTOR Putty
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Filler, Bone Void, Non-Osteoinduction | MBS | 3 | Manufacturer for export | accessdata.fda.gov |
| Filler, Bone Void, Synthetic Peptide | NOX | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| June 18, 2025 | P240001 | PearlMatrix Bone Graft | NOX | 3 | September 16, 2026 | accessdata.fda.gov |
| November 3, 2015 | P140019 | I-FACTOR PEPTIDE ENHANCED BONE GRAFT | NOX | 14 | September 16, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 29, 2025 | 98242 | Class II | Ongoing | PearMatrix P-15 Peptide Enhanced Bone Graft Bone Graft, 1.0cc REF: | Incorrect expiration date | accessdata.fda.gov |
| April 14, 2022 | 90015 | Class III | Terminated | putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF, PUTTY | Patient chart label contains incorrect Part Number and volume amount. | accessdata.fda.gov |
Compare with other makers
- All makers of Filler, Bone Void, Synthetic Peptide
- All makers of Filler, Bone Void, Non-Osteoinduction
Updated September 16, 2026. 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.