Chrysalis Intelligence · Product Codes · NHB

NHB · Polymer, Ear, Nose And Throat, Synthetic, Absorbable

Ear, Nose, Throat · 5 clearances · 2 unique sponsors

Device class
Class II
Regulation 874.3620
Total clearances
5
2022-05-05 → 2026-07-30
Last 12 months
2
Unique sponsors
2
Definition

What is Polymer, Ear, Nose And Throat, Synthetic, Absorbable

Ear, nose, and throat absorbable synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is shaped and formed by the surgeon to conform to the patient's needs. This generic type of device is made of absorbable synthetic polymer materials.
Medical specialty
Ear, Nose, Throat
Review panel
EN
Regulation number
874.3620
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Spirair, Inc. 4 2 2026-07-30
Hemostasis, LLC 1 0 2022-05-05
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.

CodeTypeDescriptionConfidenceRationale
99070 CPT — Medium Surgical supplies for ENT reconstruction
C9359 HCPCS Porous purified collagen matrix bone void filler (integra mozaik osteoconductive scaffold putty, integra os osteoconductive scaffold putty), per 0.5 cc ✓ CMS-verified description Medium Implantable absorbable material for tissue reconstruction
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-30 K260620 Spirair, Inc. SeptAlign (SPLN001)
2026-01-16 K251790 Spirair, Inc. SeptAlign
2024-03-22 K233569 Spirair, Inc. SeptAlign
2023-08-17 K223167 Spirair, Inc. Spirair Nasal Septal Strap
2022-05-05 K210411 Hemostasis, LLC PosiSep EAR Fragmentable Ear Dressing