OSTEORAPTOR SUTURE ANCHOR— 510(k) K082215
Substantially EquivalentSmith & Nephew Inc., Endoscopy Division
FDA 510(k) clearance K082215 for OSTEORAPTOR SUTURE ANCHOR, Substantially Equivalent on 2008-11-03. Applicant: Smith & Nephew Inc., Endoscopy Division. Device class: 2.
Clearance details
- Applicant
- Smith & Nephew Inc., Endoscopy Division
- Product code
- Code JDR
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Andover, MA, US
Recent devices under product code JDR
view allMore clearances from Smith & Nephew Inc., Endoscopy Division
view allAdverse events under product code JDR
product code JDR- Injury
- 726
- Malfunction
- 663
- Other
- 1
- Total
- 1,390
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K082215
K-number listed on FDA's recall record- Z-2220-2013 — OSTEORAPTOR 2.3 mm Suture Anchor with ULTRABRAID COBRAID Suture, Blue; Part Number: 72201993 Biodegradable suture anchor
- Z-2221-2013 — OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Blue ; Part Number: 72201995 Biodegradable suture anchor
- Z-2222-2013 — OSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White; Part Number: 72201991 Biodegradable suture anchor
- Z-2223-2013 — OSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black; Part Number: 72201992 Biodegradable suture anchor
- Z-2224-2013 — OSTOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Blue; Part Number: 72201994 Biodegradable suture anchor
- Z-2225-2013 — OSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Part Number: 72201996 Biodegradable suture anchor
- Z-2226-2013 — OSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Number: 72202165 Biodegradable suture anchor
- Z-2227-2013 — OSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number: 72203291 Biodegradable suture anchor
- Z-2228-2013 — OSTEORAPTOR CURVED 2.3 mm Suture Anchor SA ULTRABRAID COBRAID Suture, Blue; Part Number: 72203290 Biodegradable suture anchor
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082215.
Data sourced from openFDA. This site is unofficial and independent of the FDA.