510(k) K043034 ยท NPM Bone Grafting Material, Animal Source
OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS
| Applicant | Collagen Matrix, Inc., Franklin Lakes NJ, US |
| Decision | Substantially Equivalent, Aug 4, 2005 |
| Received | Nov 3, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043034
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2022 | Ace Surgical Supply Co., Inc. NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects.
Catalog Number: 5099250 Open, Classified |
NPM | None listed |
| Mar 11, 2016 | Collagen Matrix Inc NuOss XC Sinus
Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height)
Reference No 509-3002 (BMCU22, size 22 mm diameter x 12 m height)
Manufacturer:- Collagen Matrix,
Distributor:- ACE Terminated |
NPM | None listed |
| Aug 25, 2015 | Collagen Matrix Inc NuOSS Cancellous
Intended for use in dental surgery. Terminated |
NPM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.