FTM · Mesh, Surgical · Chrysalis Intelligence

Device class

Class II

Regulation 878.3300

Total clearances

2020-03-06 → 2026-08-12

Last 12 months

Unique sponsors

Classification details

Medical specialty

General, Plastic Surgery

Review panel

Regulation number

878.3300

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Alafair Biosciences, Inc.	3	0	2021-10-29
TELA Bio, Inc.	3	0	2024-12-19
Synovis Life Technologies. Inc. (A Subsidiary of Baxter	1	0	2021-10-27
Elutia, Inc.	1	0	2024-06-14
Synovis Life Technologies, Inc.	1	0	2023-04-07
Cook Biotech Incorporated	1	0	2020-07-13
B. Bruan Surgical, SA	1	0	2020-09-03
Geistlich Pharma AG	1	0	2021-07-14
Aziyo Biologics, Inc.	1	0	2020-06-15
Boston Scientific	1	1	2026-08-12
Aroa Biosurgery , Ltd.	1	0	2025-06-03

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
A4649	HCPCS	Surgical supply; miscellaneous ✓ CMS-verified description	High	Standard HCPCS supply code for surgical mesh
15777	CPT	—	Medium	Surgical mesh implantation/reinforcement procedure

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-08-12	K262406	Boston Scientific	EluPro Antibiotic-Eluting BioEnvelope
2025-06-03	K250598	Aroa Biosurgery , Ltd.	Endoform Reconstructive Template - PLGA
2024-12-19	K243595	TELA Bio, Inc.	OviTex PRS (Long-Term Resorbable)
2024-06-14	K233991	Elutia, Inc.	CanGaroo RM Antibacterial Envelope
2024-05-22	K241126	TELA Bio, Inc.	OviTex PRS
2023-04-07	K223052	Synovis Life Technologies, Inc.	Peri-Guard and Supple Peri-Guard
2023-03-21	K214070	Tela Bio	OviTex PRS (Long Term Resorbable)
2021-10-29	K213163	Alafair Biosciences, Inc.	VersaWrap
2021-10-27	K213125	Synovis Life Technologies. Inc. (A Subsidiary of Baxter	PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology
2021-07-14	K203496	Geistlich Pharma AG	Nexo-Gide Bilayer Collagen Membrane
2021-03-09	K203600	Alafair Biosciences, Inc.	VersaWrap
2020-09-03	K192452	B. Bruan Surgical, SA	Lyograft
2020-07-13	K201000	Cook Biotech Incorporated	Biodesign Staple Line Reinforcement
2020-06-15	K201313	Aziyo Biologics, Inc.	CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ)
2020-03-06	K200311	Alafair Biosciences, Inc.	VersaWrap Tendon Protector