510(k) K151105 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318, Smith and Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor, Smith and Nephew Suture Anchors - Osteoraptor Suture Anchor, Smith and Nephew Suture An
| Applicant | Smith & Nephew, Inc., Mansfield MA, US |
| Decision | Substantially Equivalent, Jul 28, 2015 |
| Received | Apr 24, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151105
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 9, 2020 | Smith & Nephew, Inc. TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO
Absorbable Suture anchors
Product Number: 7210309 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors
Product Number: 7210710 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors
Product Number: 7210711 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. TWINFIX 6.5MM AB PRELOADED ULTRABRAID- Absorbable Suture anchors
Product Number: 7210712 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors
Product Number: 7210713 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. TWINFIX AB 5.0 SUTR ANCHR W/2 38 ULTRA-Absorbable Suture anchors
Product Number:72200777 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors
Product Number: 72200785 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors
Product Number: 72201493 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. ULTRA FAST-FIX AB ASSEMBLY - CURVED-Absorbable Suture anchors
Product Number: 72201494 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor
Product Number: 72201495 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor
Product Number: 72201702 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. RAPTORMITE 3.7MM AB W/ NEEDLES AND TWO-Absorbable Suture anchor
Product Number: 72201805 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor
Product Number: 72201991 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor
Product Number: 72201992 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor
Product Number: 72201993 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. OSTEORAPTOR 2.9 W/ 1 UB COBRAID BLUE
-Absorbable Suture anchor
Product Number: 72201994 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. OSTEORAPTOR 2.9 W/ 2 UB WHITE / BLUE
-Absorbable Suture anchor
Product Number: 72201995 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK
-Absorbable Suture anchor
Product Number: 72201996 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor
Product Number: 72202165 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. TWINFIX ULTRA 5.5MM PLLA/HA 2 UBWHT/BL--Absorbable Suture anchor
Product Number: 72202602 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor
Product Number: 72202603 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. TWINFIX ULTRA 6.5MM PLLA/HA 2 UBWHT/BL-Absorbable Suture anchor
Product Number: 72202608 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. TWINFIX ULTRA PLLA/HA 6.5 W/3 UB- Absorbable Suture anchor
Product Number: 72202610 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor
Product Number: 72202612 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor
Product Number: 72202616 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor
Product Number: 72202620 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor
Product Number: 72202624 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor
Product Number: 72202626 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor
Product Number: 72202631 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor
Product Number: 72203290 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. OSTEORAPTOR CRVD 2.3 SA UB COBRD BLACK- Absorbable Suture anchor
Product Number: 72203291 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL- Absorbable Suture anchor
Product Number: 72203697 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor
Product Number: 72203704 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor
Product Number: 72203705 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. HEALICOIL RG SA 5.5MM W/2 UB-BL CBR BL-- Absorbable Suture anchor
Product Number: 72203706 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. HEALICOIL RG SA 5.5MM W/3 UB-BL CB BL BK- Absorbable Suture anchor
Product Number: 72203707 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor
Product Number: 72203708 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor
Product Number: 72203801 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor
Product Number: 72204983 Open, Classified |
MAI | None listed |
| Sep 9, 2020 | Smith & Nephew, Inc. MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor
Product Number: 72204984 Open, Classified |
MAI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.